Trial Outcomes & Findings for OPALINE : A Study Of Morbidity And Mortality At 2 Years (NCT NCT02264665)

NCT ID: NCT02264665

Last Updated: 2023-11-13

Results Overview

PFS was defined as time (in months) from date of start of treatment (the treatment line ongoing at the time of inclusion in the study) to first documentation of disease progression (PD) or date of death due to any cause, when receiving the main treatment at the time of inclusion. RECIST v1.1, PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment (this included baseline sum if that is smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of existing non-target lesions. Appearance of 1 or more new target or non-target lesions. If a participant did not have an event, data censoring was done at the last recorded time to PD or the last tumor assessment, last disease assessment. Analysis was performed using Kaplan-Meier method.

• Recruitment status: COMPLETED
• Target enrollment: 144 participants
• Primary outcome timeframe: At 2 years of prospective follow-up
• Results posted on: 2023-11-13

Participant Flow

This was an observational study carried out in France in adult participants treated for a well-differentiated, unresectable or metastatic, progressive pancreatic neuroendocrine tumor (pNET).

Participant milestones

Measure	Everolimus (Targeted Therapy) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Interferon-alpha (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with interferon-alpha or were being treated with interferon-alpha. Participants were prospectively followed-up for 2 years in this study.	Treatment Not Documented This reporting group consisted of those participants whose treatment was not documented at time of inclusion.
Overall Study STARTED	35	23	52	30	1	0	3
Overall Study Reference Set (Full Analysis Set)	32	23	50	28	1	0	0
Overall Study Safety Set	35	23	52	30	1	0	0
Overall Study COMPLETED	22	15	31	21	1	0	0
Overall Study NOT COMPLETED	13	8	21	9	0	0	3

Reasons for withdrawal

Measure	Everolimus (Targeted Therapy) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Interferon-alpha (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with interferon-alpha or were being treated with interferon-alpha. Participants were prospectively followed-up for 2 years in this study.	Treatment Not Documented This reporting group consisted of those participants whose treatment was not documented at time of inclusion.
Overall Study Other	0	0	3	0	0	0	0
Overall Study Death	9	8	13	5	0	0	1
Overall Study Lost to Follow-up	1	0	2	1	0	0	0
Overall Study Participant decision	0	0	0	1	0	0	0
Overall Study Inclusion/non-inclusion criteria not respected	3	0	2	2	0	0	2
Overall Study Data Missing	0	0	1	0	0	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Everolimus (Targeted Therapy) at Inclusion n=32 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=23 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion n=50 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion n=28 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion n=1 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Total n=134 Participants Total of all reporting groups
Age, Continuous	61.16 Years STANDARD_DEVIATION 12.56 • n=32 Participants	64.19 Years STANDARD_DEVIATION 12.27 • n=23 Participants	62.06 Years STANDARD_DEVIATION 12.39 • n=50 Participants	66.77 Years STANDARD_DEVIATION 12.76 • n=28 Participants	82.38 Years n=1 Participants	63.35 Years STANDARD_DEVIATION 12.58 • n=134 Participants
Sex: Female, Male Female	18 Participants n=32 Participants	5 Participants n=23 Participants	18 Participants n=50 Participants	11 Participants n=28 Participants	1 Participants n=1 Participants	53 Participants n=134 Participants
Sex: Female, Male Male	14 Participants n=32 Participants	18 Participants n=23 Participants	32 Participants n=50 Participants	17 Participants n=28 Participants	0 Participants n=1 Participants	81 Participants n=134 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: At 2 years of prospective follow-up

Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

PFS was defined as time (in months) from date of start of treatment (the treatment line ongoing at the time of inclusion in the study) to first documentation of disease progression (PD) or date of death due to any cause, when receiving the main treatment at the time of inclusion. RECIST v1.1, PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment (this included baseline sum if that is smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of existing non-target lesions. Appearance of 1 or more new target or non-target lesions. If a participant did not have an event, data censoring was done at the last recorded time to PD or the last tumor assessment, last disease assessment. Analysis was performed using Kaplan-Meier method.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=32 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=23 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion n=50 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion n=27 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion n=1 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study Participants who received treatment other than the study treatments at least once in the study.
Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion	26.5 Percentage of participants Interval 10.3 to 46.0	19.3 Percentage of participants Interval 4.6 to 41.4	36.5 Percentage of participants Interval 13.8 to 60.0	38.6 Percentage of participants Interval 16.0 to 61.0	NA Percentage of participants Survival analysis not performed with only one participant at risk.	—

PRIMARY outcome

Timeframe: At 2 years of prospective follow-up

Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

PFS was defined as time (in months) from date of start of treatment (the treatment line ongoing at the time of inclusion in the study) to first documentation of PD or date of death due to any cause, when receiving the main treatment at the time of inclusion. RECIST v1.1, PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment (this included baseline sum if that is smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of 1 or more new target or non-target lesions. If a participant did not have an event, data censoring was done at the last recorded time to PD or the last tumor assessment, last disease assessment. Analysis was performed using Kaplan-Meier method.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=55 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=78 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study Participants who received treatment other than the study treatments at least once in the study.
PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion	19.9 Percentage of participants Interval 9.2 to 33.4	29.0 Percentage of participants Interval 14.7 to 45.0	—	—	—	—

PRIMARY outcome

Timeframe: At 2 years of prospective follow-up

Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here, "Overall Number of Participants" signifies number of participants evaluable for this outcome measure.

OS was the percentage of participants who were alive at 2 years of prospective follow-up. OS was defined as the time (in months) from the date of start of treatment (of the treatment line ongoing at the time of inclusion in the study) to the date of death due to any cause. Participants with no event or lost to follow-up or alive at the end of the study were censored at their last follow-up date (last follow-up date or last news). Analysis was performed using Kaplan-Meier method.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=32 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=23 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion n=50 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion n=28 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion n=1 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study Participants who received treatment other than the study treatments at least once in the study.
Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion	60.2 Percentage of participants Interval 37.6 to 76.8	68.4 Percentage of participants Interval 37.8 to 86.2	69.6 Percentage of participants Interval 52.6 to 81.6	79.7 Percentage of participants Interval 48.0 to 93.2	NA Percentage of participants Survival analysis not performed with only one participant at risk.	—

PRIMARY outcome

Timeframe: At 2 years of prospective follow-up

Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here, "Overall Number of Participants" signifies number of participants evaluable for this outcome measure.

OS was the percentage of participants who were alive at 2 years of prospective follow-up. OS was defined as the time (in months) from the date of start of treatment (of the treatment line ongoing at the time of inclusion in the study) to the date of death due to any cause. Participants with no event or lost to follow-up or alive at the end of the study were censored at their last follow-up date (last follow-up date or last news). Analysis was performed using Kaplan-Meier method.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=55 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=79 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study Participants who received treatment other than the study treatments at least once in the study.
OS Rate at 2 Years- Based on Targeted Therapy Group and Other Treatments Group at Inclusion	63.9 Percentage of participants Interval 46.8 to 76.8	71.7 Percentage of participants Interval 57.2 to 82.1	—	—	—	—

PRIMARY outcome

Timeframe: During 2 years of prospective follow-up

Population: Safety analysis set included participants who received at least one dose of the documented treatment in the study (targeted therapy or other treatment). If the participant was prevalent, the treatment must still be ongoing at the time of inclusion in the study and if the participant was incident, the treatment must be started at or after inclusion in the study. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=20 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=22 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study Participants who received treatment other than the study treatments at least once in the study.
Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion Participant's choice	3 Participants	3 Participants	—	—	—	—
Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion Other	4 Participants	2 Participants	—	—	—	—
Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion Adverse event	12 Participants	6 Participants	—	—	—	—
Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion Doctor's choice	1 Participants	11 Participants	—	—	—	—

PRIMARY outcome

Timeframe: During 2 years of prospective follow-up

Population: Safety analysis set. Since participants were grouped on the basis of type of treatment they received at least once during 2 years of follow-up, participants are not exclusive per treatment arm. One participant could have received more than 1 type of treatment during these 2 years.

AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: any AE, regardless of dose, that: led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. Treatment-related AE was any untoward medical occurrence attributed to study drug in participant who received study drug. Relatedness to treatment was assessed by investigator. Per CTCAE 4.0, Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4=Life-threatening events Grade 5 (Death) events=death related to an AE. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=52 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=36 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion n=82 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion n=65 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion n=11 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study n=16 Participants Participants who received treatment other than the study treatments at least once in the study.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study At least one AE of grade 4 or higher	6 Participants	2 Participants	18 Participants	16 Participants	2 Participants	1 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study AE	43 Participants	32 Participants	63 Participants	48 Participants	6 Participants	8 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study Treatment Related AE	31 Participants	24 Participants	48 Participants	13 Participants	2 Participants	0 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study SAE	21 Participants	9 Participants	26 Participants	24 Participants	3 Participants	3 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study Treatment Related SAE	6 Participants	2 Participants	5 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study At least one grade 3 AE	21 Participants	11 Participants	18 Participants	14 Participants	1 Participants	3 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study At least one grade 3 SAE	14 Participants	6 Participants	12 Participants	12 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: During 2 years of prospective follow-up

Population: Safety analysis set. Since participants were grouped on the basis of type of treatment they received at least once during 2 years of follow-up, participants are not exclusive per treatment arm. One participant could have received more than 1 type of treatment during these 2 years.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=52 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=36 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion n=82 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion n=65 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion n=11 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study n=16 Participants Participants who received treatment other than the study treatments at least once in the study.
Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study Temporary discontinuation of treatment	15 Participants	9 Participants	11 Participants	8 Participants	0 Participants	1 Participants
Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study Permanent discontinuation of treatment	14 Participants	10 Participants	12 Participants	12 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: During 2 years of prospective follow-up

Population: Safety analysis set. Since participants were grouped on the basis of type of treatment they received at least once during 2 years of follow-up, participants are not exclusive per treatment arm. One participant could have received more than 1 type of treatment during these 2 years.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events leading to death are reported in this outcome measure. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=52 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=36 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion n=82 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion n=65 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion n=11 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study n=16 Participants Participants who received treatment other than the study treatments at least once in the study.
Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study	3 Participants	2 Participants	11 Participants	12 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: During 2 years of prospective follow-up

Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=55 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=79 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study Participants who received treatment other than the study treatments at least once in the study.
Mean of Number of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion	5.8 Visits Standard Deviation 2.7	5.5 Visits Standard Deviation 2.7	—	—	—	—

SECONDARY outcome

Timeframe: During 2 years of prospective follow-up

Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.

Frequency = number of tumor assessment visits /([last visit date - baseline date]/365.25).

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=55 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=79 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study Participants who received treatment other than the study treatments at least once in the study.
Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 2 tests per annum	3 Participants	4 Participants	—	—	—	—
Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 3 tests per annum	19 Participants	26 Participants	—	—	—	—
Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 4 tests per annum	18 Participants	30 Participants	—	—	—	—
Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 5 tests per annum	10 Participants	10 Participants	—	—	—	—
Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 6 tests per annum	2 Participants	4 Participants	—	—	—	—
Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 7 tests per annum	1 Participants	0 Participants	—	—	—	—
Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 9 tests per annum	0 Participants	2 Participants	—	—	—	—
Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 0 tests per annum	2 Participants	3 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During 2 years of prospective follow-up

Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

The different types of investigations were performed for assessment of tumor regardless of treatment received. Investigations performed were Computed Tomography (CT) scan, Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) scan, Octreoscan, Ultrasound. All the investigations were used at least once during the study for all treatments.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=53 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=76 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study Participants who received treatment other than the study treatments at least once in the study.
Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion CT Scan	48 Participants	65 Participants	—	—	—	—
Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion MRI	28 Participants	45 Participants	—	—	—	—
Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion PET Scan	11 Participants	15 Participants	—	—	—	—
Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion Octreoscan	13 Participants	15 Participants	—	—	—	—
Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion Ultrasound	6 Participants	4 Participants	—	—	—	—
Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion Imaging (CT scan and/or MRI)	52 Participants	74 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During 2 years of prospective follow-up

Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.

In this outcome measure, number of participants with a change in treatment compared to treatment at inclusion is reported.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=55 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=79 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study Participants who received treatment other than the study treatments at least once in the study.
Number of Participants Who Had a Change in Their Treatment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion	44 Participants	68 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During 2 years of prospective follow-up

Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.

Number of participants according to number of changes in doses of treatment is reported for this outcome measure.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=32 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=23 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion n=50 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion n=28 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study Participants who received treatment other than the study treatments at least once in the study.
Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion 2	1 Participants	2 Participants	3 Participants	0 Participants	—	—
Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion 0	25 Participants	18 Participants	40 Participants	21 Participants	—	—
Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion 1	4 Participants	3 Participants	7 Participants	7 Participants	—	—
Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion 4	2 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: During 2 years of prospective follow-up

Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.

Number of participants according to course of changes in doses of treatment is reported for this outcome measure.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=1 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study Participants who received treatment other than the study treatments at least once in the study.
Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion 0	0 Participants	—	—	—	—	—
Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion 1	0 Participants	—	—	—	—	—
Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion 2	0 Participants	—	—	—	—	—
Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion 4	1 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: During 2 years of prospective follow-up

Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.

The number of lines of combined main treatment administered during the study were assessed.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=55 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=79 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study Participants who received treatment other than the study treatments at least once in the study.
Number of Combined Main Lines of Treatments Received - Based on Targeted Therapy Group and Other Treatments Group at Inclusion	3.9 Treatment lines Standard Deviation 1.7	2.9 Treatment lines Standard Deviation 1.6	—	—	—	—

SECONDARY outcome

Timeframe: During 2 years of prospective follow-up

Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.

The number of main lines of treatment received during the study treatment are reported in this outcome measure.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=55 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=79 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study Participants who received treatment other than the study treatments at least once in the study.
Number of Main Lines of Treatment Received During the Study - Based on Targeted Therapy Group and Other Treatments Group at Inclusion	3.7 Treatment lines Standard Deviation 1.7	2.8 Treatment lines Standard Deviation 1.5	—	—	—	—

SECONDARY outcome

Timeframe: During 2 years of prospective follow-up

Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.

The types of main lines of treatment included 1st line, 2nd line, 3rd line, 4th line, 5th line, 6th line, 7th line and 8th line.

Outcome measures

Measure	Everolimus (Targeted Therapy) at Inclusion n=55 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study.	Sunitinib (Targeted Therapy) at Inclusion n=79 Participants Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.	Chemotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.	Somatostatin Analogues (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.	Metabolic Radiotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.	Other Than Study Treatments During Study Participants who received treatment other than the study treatments at least once in the study.
Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 1st line	8 Participants	38 Participants	—	—	—	—
Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 2nd line	27 Participants	43 Participants	—	—	—	—
Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 3rd line	25 Participants	30 Participants	—	—	—	—
Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 4th line	28 Participants	26 Participants	—	—	—	—
Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 5th line	15 Participants	15 Participants	—	—	—	—
Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 6th line	7 Participants	2 Participants	—	—	—	—
Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 7th line	4 Participants	1 Participants	—	—	—	—
Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion 8th line	2 Participants	0 Participants	—	—	—	—

Adverse Events

Everolimus During Study

Serious events: 21 serious events

Other events: 39 other events

Deaths: 4 deaths

Sunitinib During Study

Serious events: 9 serious events

Other events: 29 other events

Deaths: 3 deaths

Chemotherapy During Study

Serious events: 26 serious events

Other events: 56 other events

Deaths: 15 deaths

Somatostatin Analogues During Study

Serious events: 24 serious events

Other events: 41 other events

Deaths: 14 deaths

Metabolic Radiotherapy During Study

Serious events: 3 serious events

Other events: 4 other events

Deaths: 2 deaths

Other Than Study Treatment During Study

Serious events: 3 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Measure	Everolimus During Study n=52 participants at risk Participants who received everolimus at least once in the study.	Sunitinib During Study n=36 participants at risk Participants who received sunitinib at least once in the study.	Chemotherapy During Study n=82 participants at risk Participants who received chemotherapy at least once in the study.	Somatostatin Analogues During Study n=65 participants at risk Participants who received somatostatin analogues at least once in the study.	Metabolic Radiotherapy During Study n=11 participants at risk Participants who received metabolic radiotherapy at least once in the study.	Other Than Study Treatment During Study n=16 participants at risk Participants who received treatment other than the study treatments at least once in the study.
Hepatobiliary disorders Portal hypertension	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Renal and urinary disorders Acute kidney injury	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Disease progression	5.8% 3/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	5.6% 2/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.1% 5/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	12.3% 8/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders General physical health deterioration	7.7% 4/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	4.9% 4/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 4/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Condition aggravated	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.4% 2/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Death	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Pyrexia	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Mucosal inflammation	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Oedema	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Pain	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Abdominal pain upper	5.8% 3/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.1% 2/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Intestinal obstruction	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.4% 2/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.1% 2/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Abdominal pain	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Gastric varices	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.4% 2/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Vomiting	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.1% 2/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	9.1% 1/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Haematemesis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Mesenteric vein thrombosis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Pancreatitis acute	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Subileus	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Sepsis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Device related sepsis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	9.1% 1/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Endocarditis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Enterobacter sepsis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Erysipelas	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Escherichia bacteraemia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Implant site infection	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Oesophageal candidiasis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Peritonitis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Prostatitis Escherichia coli	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Staphylococcal sepsis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Urinary tract infection	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Hepatobiliary disorders Cholangitis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.4% 2/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Hepatobiliary disorders Hepatocellular injury	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	5.6% 2/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.1% 2/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Hepatobiliary disorders Cholecystitis acute	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Hepatobiliary disorders Cholestasis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Renal and urinary disorders Renal colic	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Renal and urinary disorders Renal failure	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Renal and urinary disorders Urinary retention	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Respiratory, thoracic and mediastinal disorders Lung disorder	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	18.2% 2/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Blood and lymphatic system disorders Anaemia	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Blood and lymphatic system disorders Thrombocytopenia	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Cardiac disorders Cardiac failure	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.4% 2/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Cardiac disorders Coronary artery stenosis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Injury, poisoning and procedural complications Chemical peritonitis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Injury, poisoning and procedural complications Fall	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Injury, poisoning and procedural complications Femur fracture	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Injury, poisoning and procedural complications Overdose	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Fluid retention	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Hypercalcaemia	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Hyperkalaemia	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Musculoskeletal and connective tissue disorders Back pain	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Erythema	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Urticaria	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Vascular disorders Peripheral ischaemia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Vascular disorders Venous thrombosis limb	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Complex regional pain syndrome	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Product Issues Device occlusion	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Psychiatric disorders Confusional state	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.

Other adverse events

Measure	Everolimus During Study n=52 participants at risk Participants who received everolimus at least once in the study.	Sunitinib During Study n=36 participants at risk Participants who received sunitinib at least once in the study.	Chemotherapy During Study n=82 participants at risk Participants who received chemotherapy at least once in the study.	Somatostatin Analogues During Study n=65 participants at risk Participants who received somatostatin analogues at least once in the study.	Metabolic Radiotherapy During Study n=11 participants at risk Participants who received metabolic radiotherapy at least once in the study.	Other Than Study Treatment During Study n=16 participants at risk Participants who received treatment other than the study treatments at least once in the study.
General disorders Asthenia	9.6% 5/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	16.7% 6/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	29.3% 24/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	12.3% 8/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	9.1% 1/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	12.5% 2/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Mucosal inflammation	15.4% 8/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	8.3% 3/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.4% 2/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	4.6% 3/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Oedema peripheral	9.6% 5/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.7% 3/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	4.6% 3/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	12.5% 2/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Pyrexia	7.7% 4/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	5.6% 2/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	4.9% 4/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders General physical health deterioration	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Pain	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 4/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	9.1% 1/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Fatigue	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	9.1% 1/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Oedema	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Chest discomfort	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Chest pain	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Device related thrombosis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Disease progression	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Drug intolerance	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Face oedema	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Gait disturbance	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Hernia	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Impaired healing	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Injection site swelling	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Non-cardiac chest pain	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
General disorders Xerosis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Diarrhoea	11.5% 6/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	25.0% 9/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	14.6% 12/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	16.9% 11/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	18.2% 2/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	18.8% 3/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Nausea	7.7% 4/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	17.1% 14/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 4/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Vomiting	5.8% 3/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	11.1% 4/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	8.5% 7/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	4.6% 3/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	9.1% 1/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	12.5% 2/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.1% 5/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.1% 2/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Aphthous ulcer	11.5% 6/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	5.6% 2/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	11.1% 4/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.7% 3/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	8.3% 3/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.7% 3/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Constipation	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	4.9% 4/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Abdominal distension	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	4.6% 3/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Dyspepsia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	5.6% 2/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Anal inflammation	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Ascites	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Dry mouth	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Dysphagia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Gastritis erosive	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Gastrointestinal hypermotility	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Gastrointestinal toxicity	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Hyperchlorhydria	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Oedema mouth	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Oesophagitis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Stomatitis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Subileus	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Gastrointestinal disorders Toothache	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Dysgeusia	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	13.9% 5/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.7% 3/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	7.7% 5/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	18.2% 2/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Neuropathy peripheral	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	11.0% 9/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Paraesthesia	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	7.3% 6/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.1% 2/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Headache	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Neurotoxicity	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.7% 3/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Dysaesthesia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.4% 2/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Hyperaesthesia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Sciatica	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Amnesia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Burning sensation	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Dizziness	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Epilepsy	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Memory impairment	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Parosmia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Psychomotor skills impaired	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Restless legs syndrome	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Nervous system disorders Taste disorder	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	9.1% 1/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Blood and lymphatic system disorders Neutropenia	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	22.2% 8/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	8.5% 7/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	4.6% 3/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Blood and lymphatic system disorders Thrombocytopenia	5.8% 3/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	8.3% 3/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	12.2% 10/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	4.6% 3/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Blood and lymphatic system disorders Anaemia	7.7% 4/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	5.6% 2/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.7% 3/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 4/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	9.1% 1/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Blood and lymphatic system disorders Leukopenia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.4% 2/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	9.1% 1/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	9.1% 1/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Blood and lymphatic system disorders Hyperleukocytosis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Blood and lymphatic system disorders Macrocytosis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Blood and lymphatic system disorders Microcytic anaemia	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Blood and lymphatic system disorders Pancytopenia	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Bronchitis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.7% 3/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Gastroenteritis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	4.6% 3/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Urinary tract infection	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.1% 2/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Folliculitis	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Herpes zoster	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Oral fungal infection	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Tooth abscess	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Abscess neck	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Dermatophytosis of nail	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Ear infection	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Erysipelas	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Gingivitis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Influenza	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Laryngitis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Lung infection	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Oral herpes	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Pneumonia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Pyelonephritis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Sepsis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Musculoskeletal and connective tissue disorders Arthralgia	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.7% 3/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	4.6% 3/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Musculoskeletal and connective tissue disorders Back pain	7.7% 4/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	4.6% 3/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	12.5% 2/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Musculoskeletal and connective tissue disorders Myalgia	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.4% 2/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.1% 2/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Musculoskeletal and connective tissue disorders Amyotrophy	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Musculoskeletal and connective tissue disorders Muscle fatigue	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Musculoskeletal and connective tissue disorders Tenosynovitis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Injury, poisoning and procedural complications Nail injury	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Decreased appetite	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	5.6% 2/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	7.3% 6/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 4/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	12.5% 2/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Hyperglycaemia	7.7% 4/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.1% 2/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Hypoglycaemia	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Cell death	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Hypercholesterolaemia	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.4% 2/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Diabetes mellitus	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Fluid retention	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Hypertriglyceridaemia	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Hypocalcaemia	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Metabolism and nutrition disorders Malnutrition	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	11.1% 4/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	4.6% 3/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	9.1% 1/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.4% 2/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Hair colour changes	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	8.3% 3/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Rash	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Rash erythematous	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Eczema	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Hair disorder	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Madarosis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Onychoclasis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Palmar erythema	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Pigmentation disorder	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Plantar erythema	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Skin burning sensation	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Skin fissures	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Skin toxicity	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Skin and subcutaneous tissue disorders Urticaria	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Investigations Weight decreased	7.7% 4/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	5.6% 2/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.4% 2/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	4.6% 3/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	18.8% 3/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Investigations Blood phosphorus decreased	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	8.3% 3/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.4% 2/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Investigations Blood alkaline phosphatase increased	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.1% 2/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Investigations Alanine aminotransferase increased	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Investigations Aspartate aminotransferase increased	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Investigations Blood calcium abnormal	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Investigations Blood creatine phosphokinase increased	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Investigations Blood sodium abnormal	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Investigations Gammaglutamyltransferase increased	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Investigations Liver function test abnormal	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Investigations Lymphocyte count decreased	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Investigations Prothrombin time ratio decreased	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Investigations Transaminases increased	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Respiratory, thoracic and mediastinal disorders Cough	5.8% 3/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	5.6% 2/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	5.6% 2/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Respiratory, thoracic and mediastinal disorders Increased bronchial secretion	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Respiratory, thoracic and mediastinal disorders Lung disorder	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Renal and urinary disorders Acute kidney injury	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	3.1% 2/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Renal and urinary disorders Renal failure	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.4% 2/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Renal and urinary disorders Renal impairment	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Renal and urinary disorders Nocturia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Renal and urinary disorders Polyuria	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Renal and urinary disorders Prerenal failure	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Renal and urinary disorders Proteinuria	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Cardiac disorders Tachycardia	3.8% 2/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Cardiac disorders Arrhythmia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Cardiac disorders Atrial fibrillation	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Cardiac disorders Atrial flutter	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Cardiac disorders Cardiac failure	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Cardiac disorders Pericardial disease	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Injury, poisoning and procedural complications Head injury	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Injury, poisoning and procedural complications Overdose	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Injury, poisoning and procedural complications Persistent corneal epithelial defect	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Vascular disorders Hot flush	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.4% 2/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Vascular disorders Hypertension	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Vascular disorders Peripheral venous disease	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Vascular disorders Phlebitis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Vascular disorders Thrombosis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Vascular disorders Venous thrombosis limb	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Hepatobiliary disorders Hepatic pain	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	6.2% 1/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Hepatobiliary disorders Cholangitis chronic	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Hepatobiliary disorders Cholangitis sclerosing	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Hepatobiliary disorders Cholestasis	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Hepatobiliary disorders Hepatocellular injury	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Hepatobiliary disorders Hepatomegaly	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Ear and labyrinth disorders Vertigo	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Ear and labyrinth disorders Hypoacusis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Ear and labyrinth disorders Sudden hearing loss	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Ear and labyrinth disorders Tinnitus	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Psychiatric disorders Depressive symptom	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Psychiatric disorders Disorientation	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Psychiatric disorders Insomnia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Psychiatric disorders Nervousness	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Psychiatric disorders Sleep disorder	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Eye disorders Eyelid oedema	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Eye disorders Lacrimation increased	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Eye disorders Visual acuity reduced	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ear neoplasm malignant	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	9.1% 1/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	1.9% 1/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	2.8% 1/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Endocrine disorders Diabetes insipidus	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Reproductive system and breast disorders Gynaecomastia	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.5% 1/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.
Surgical and medical procedures Liver transplant	0.00% 0/52 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/36 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	1.2% 1/82 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/65 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/11 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.	0.00% 0/16 • During 2 years of prospective follow-up Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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