Trial Outcomes & Findings for A Study of Ponatinib in Japanese Participants With Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL) (NCT NCT01667133)

NCT ID: NCT01667133

Last Updated: 2022-06-13

Results Overview

DLT was evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 and was defined as any of the following events: 1. Grade greater than or equal to (\>=) 3 non-hematologic, with the exception of medically controllable toxicities (example; nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting \<=3 days, but excluding alopecia; 2. Missed doses: \>25% of planned ponatinib doses over 28 days due to AEs in the first cycle; 3. Febrile neutropenia (the occurrence of an ANC \<500/microliter concurrently with a temperature elevation of \>101 degree Fahrenheit), when neutropenia is not related to underlying acute leukemia, as defined hematologic toxicity: Dose-limiting hematologic toxicity is the occurrence of a Grade 4 cytopenia \>28 days, not related to underlying disease according to the investigator. Bone marrow examination must demonstrate \<5% cellularity.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: Cycle 1 (Cycle length= 28 days)
• Results posted on: 2022-06-13

Participant Flow

Participants took part in the study at 9 investigative sites in Japan from 31 August 2012 to 02 August 2018.

Participants with CP-CML, AP-CML, or BP-CML, or with Ph+ALL were enrolled in Phase 1 (dose-escalation) to receive 30 or 45 mg of ponatinib and recommended phase 2 dose in Phase 2 (expansion). As there was no participant enrolled in Phase 1: BP-CML Ponatinib 30 milligram (mg) arm, therefore the arm is not reported in the result summary. Participants in Phase 1 with CP-CML or AP-CML, BP-CML or Ph+ ALL and who had T315I mutation and other mutations were analyzed as subgroups in the study.

Participant milestones

Measure	Ponatinib 30 mg: Phase 1 CP-CML Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with chronic phase (CP)-chronic myeloid leukemia (CML) resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 AP-CML Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with accelerated phase (AP)- CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Philadelphia chromosome plus acute lymphoblastic leukemia (Ph+ ALL) resistant or intolerant to prior tyrosine kinase inhibitor (TKIs) in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP- CML Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).	Ponatinib 15 mg: Phase 2 Ph+ ALL Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).	Ponatinib 45 mg: Phase 2 CP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 BP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 PH+ ALL Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
Phase 1: Dose-escalation STARTED	1	1	4	3	1	1	1	0	0	0	0	0
Phase 1: Dose-escalation COMPLETED	1	0	0	2	0	0	0	0	0	0	0	0
Phase 1: Dose-escalation NOT COMPLETED	0	1	4	1	1	1	1	0	0	0	0	0
Phase 2: Dose-expansion STARTED	0	0	0	0	0	0	0	2	1	11	3	6
Phase 2: Dose-expansion COMPLETED	0	0	0	0	0	0	0	0	0	5	0	0
Phase 2: Dose-expansion NOT COMPLETED	0	0	0	0	0	0	0	2	1	6	3	6

Reasons for withdrawal

Measure	Ponatinib 30 mg: Phase 1 CP-CML Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with chronic phase (CP)-chronic myeloid leukemia (CML) resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 AP-CML Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with accelerated phase (AP)- CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Philadelphia chromosome plus acute lymphoblastic leukemia (Ph+ ALL) resistant or intolerant to prior tyrosine kinase inhibitor (TKIs) in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP- CML Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).	Ponatinib 15 mg: Phase 2 Ph+ ALL Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).	Ponatinib 45 mg: Phase 2 CP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 BP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 PH+ ALL Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
Phase 1: Dose-escalation Adverse Event	0	0	1	0	0	0	0	0	0	0	0	0
Phase 1: Dose-escalation Lack of Efficacy	0	0	1	0	0	0	0	0	0	0	0	0
Phase 1: Dose-escalation Progressive Disease	0	1	2	0	1	1	1	0	0	0	0	0
Phase 1: Dose-escalation Withdrawal by Subject	0	0	0	1	0	0	0	0	0	0	0	0
Phase 2: Dose-expansion Adverse Event	0	0	0	0	0	0	0	2	1	1	0	0
Phase 2: Dose-expansion Lack of Efficacy	0	0	0	0	0	0	0	0	0	2	0	0
Phase 2: Dose-expansion Progressive Disease	0	0	0	0	0	0	0	0	0	0	3	5
Phase 2: Dose-expansion Withdrawal by Subject	0	0	0	0	0	0	0	0	0	2	0	0
Phase 2: Dose-expansion Death	0	0	0	0	0	0	0	0	0	1	0	0
Phase 2: Dose-expansion Other	0	0	0	0	0	0	0	0	0	0	0	1

Baseline Characteristics

A Study of Ponatinib in Japanese Participants With Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL)

Baseline characteristics by cohort

Measure	Ponatinib 30 mg: Phase 1 CP-CML n=1 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 AP-CML n=1 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL n=4 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML n=3 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP-CML n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML n=2 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months).	Ponatinib 15 mg: Phase 2 Ph+ ALL n=1 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).	Ponatinib 45 mg: Phase 2 CP-CML n=11 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 BP-CML n=3 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 PH+ ALL n=6 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.	Total n=35 Participants Total of all reporting groups
Time Since Diagnosis to Date of First Dose	10.29 years n=5 Participants	21.65 years n=7 Participants	1.51 years n=5 Participants	3.47 years n=4 Participants	10.87 years n=21 Participants	0.53 years n=8 Participants	3.00 years n=8 Participants	12.98 years n=24 Participants	0.73 years n=42 Participants	3.76 years n=42 Participants	1.69 years n=42 Participants	0.91 years n=42 Participants	2.11 years n=36 Participants
Participants with Extramedullary Involvement Hepatomegaly	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants
Age, Continuous	61.0 years n=5 Participants	62.0 years n=7 Participants	56.5 years STANDARD_DEVIATION 11.73 • n=5 Participants	60.7 years STANDARD_DEVIATION 12.86 • n=4 Participants	57.0 years n=21 Participants	58.0 years n=8 Participants	30.0 years n=8 Participants	61.5 years STANDARD_DEVIATION 14.85 • n=24 Participants	76.0 years n=42 Participants	59.1 years STANDARD_DEVIATION 13.78 • n=42 Participants	67.7 years STANDARD_DEVIATION 4.04 • n=42 Participants	58.3 years STANDARD_DEVIATION 13.78 • n=42 Participants	59.4 years STANDARD_DEVIATION 12.44 • n=36 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	6 Participants n=42 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants	15 Participants n=36 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	5 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	20 Participants n=36 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	11 Participants n=42 Participants	3 Participants n=42 Participants	6 Participants n=42 Participants	35 Participants n=36 Participants
Region of Enrollment Japan	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	11 Participants n=42 Participants	3 Participants n=42 Participants	6 Participants n=42 Participants	35 Participants n=36 Participants
Weight	67.0 kilogram (kg) n=5 Participants	57.0 kilogram (kg) n=7 Participants	45.8 kilogram (kg) STANDARD_DEVIATION 3.93 • n=5 Participants	74.1 kilogram (kg) STANDARD_DEVIATION 6.49 • n=4 Participants	55.8 kilogram (kg) n=21 Participants	60.0 kilogram (kg) n=8 Participants	54.6 kilogram (kg) n=8 Participants	60.0 kilogram (kg) STANDARD_DEVIATION 8.49 • n=24 Participants	60.5 kilogram (kg) n=42 Participants	59.0 kilogram (kg) STANDARD_DEVIATION 9.93 • n=42 Participants	54.0 kilogram (kg) STANDARD_DEVIATION 10.99 • n=42 Participants	53.7 kilogram (kg) STANDARD_DEVIATION 11.84 • n=42 Participants	57.5 kilogram (kg) STANDARD_DEVIATION 10.54 • n=36 Participants
Height	163.6 centimeter (cm) n=5 Participants	155.9 centimeter (cm) n=7 Participants	165.1 centimeter (cm) STANDARD_DEVIATION 8.89 • n=5 Participants	172.4 centimeter (cm) STANDARD_DEVIATION 6.61 • n=4 Participants	170.5 centimeter (cm) n=21 Participants	156.4 centimeter (cm) n=8 Participants	170.7 centimeter (cm) n=8 Participants	169.5 centimeter (cm) STANDARD_DEVIATION 2.83 • n=24 Participants	166.0 centimeter (cm) n=42 Participants	159.5 centimeter (cm) STANDARD_DEVIATION 10.15 • n=42 Participants	162.4 centimeter (cm) STANDARD_DEVIATION 6.92 • n=42 Participants	158.0 centimeter (cm) STANDARD_DEVIATION 8.95 • n=42 Participants	162.5 centimeter (cm) STANDARD_DEVIATION 8.95 • n=36 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 = Fully Active	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	11 Participants n=42 Participants	1 Participants n=42 Participants	6 Participants n=42 Participants	28 Participants n=36 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 = Restricted in Physical Activity; Ambulatory	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	7 Participants n=36 Participants
Participants with Initial Diagnosis of Leukemia CP-CML	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	11 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	20 Participants n=36 Participants
Participants with Initial Diagnosis of Leukemia AP-CML	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Participants with Initial Diagnosis of Leukemia BP-CML	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants
Participants with Initial Diagnosis of Leukemia Ph+ ALL	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	6 Participants n=42 Participants	12 Participants n=36 Participants
Participants with Extramedullary Involvement Splenomegaly	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Participants with Extramedullary Involvement No extramedullary involvement	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	11 Participants n=42 Participants	2 Participants n=42 Participants	6 Participants n=42 Participants	33 Participants n=36 Participants
Participants with BCR-ABL Ratio Greater than (>)0.1 - less than or equal to (<=)1%	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=36 Participants
Participants with BCR-ABL Ratio >1 to <=10 percent (%)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=36 Participants
Participants with BCR-ABL Ratio >10%	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	7 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	19 Participants n=36 Participants
Participants with BCR-ABL Ratio e1a2 variant	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	4 Participants n=42 Participants	10 Participants n=36 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Cycle length= 28 days)

Population: DLT evaluable population (Phase 1 only) included all participants who had completed at least 75% of their planned doses during Cycle 1, unless missed doses were due to adverse events (AEs).

DLT was evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 and was defined as any of the following events: 1. Grade greater than or equal to (>=) 3 non-hematologic, with the exception of medically controllable toxicities (example; nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting <=3 days, but excluding alopecia; 2. Missed doses: >25% of planned ponatinib doses over 28 days due to AEs in the first cycle; 3. Febrile neutropenia (the occurrence of an ANC <500/microliter concurrently with a temperature elevation of >101 degree Fahrenheit), when neutropenia is not related to underlying acute leukemia, as defined hematologic toxicity: Dose-limiting hematologic toxicity is the occurrence of a Grade 4 cytopenia >28 days, not related to underlying disease according to the investigator. Bone marrow examination must demonstrate <5% cellularity.

Outcome measures

Measure	Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 15 mg n=1 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.	Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 30 mg: Phase 1 AP-CML n=1 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL n=4 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML n=3 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP CML n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs) as a Measure of Safety Profile to Determine Recommended Dose of Ponatinib	—	—	—	—	0 Participants	—	—	—	—	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Baseline up to 60 months

Population: Treated population included all participants who had received at least 1 dose of study drug. This outcome measure was planned to be assessed only in CP-CML participants of Phase 2.

MCyR was defined as percentage of participants who achieved a complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR) after the initiation of study treatment. Cytogenic response was the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow. CCyR: no Ph+ cells. PCyR: 1% to 35% Ph+ cells. Participants entering the study already in PCyR had to achieve a CCyR in order to be considered a success for the confirmed MCyR rate.

Outcome measures

Measure	Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 15 mg n=2 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.	Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 30 mg: Phase 1 AP-CML n=11 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
Phase 2, CP-CML Participants: Percentage of Participants With Major Cytogenetic Response (MCyR)	—	—	—	—	50 percentage of participants Interval 1.3 to 98.7	—	—	—	—	63.6 percentage of participants Interval 30.8 to 89.1	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline up to 60 months

Population: Treated population included all participants who had received at least 1 dose of study drug. This outcome measure was planned to be assessed only in BP-CML and Ph+ALL participants of Phase 2.

MaHR was defined as percentage of participants with complete hematologic response (CHR) or no evidence of leukemia (NEL). MaHR response was confirmed by a peripheral blood complete blood count (CBC) and differential no earlier than 28 days after the response was observed. Response criteria for CHR was reported as white blood cells (WBC)<=institutional upper limit of normal (ULN), absolute neutrophil count (ANC)>=1000/mm^3, platelets>=100,000/mm^3, no blasts or promyelocytes in peripheral blood, BM blasts <=5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement; Response criteria for NEL reported as WBC<=institutional ULN, no blasts or promyelocytes in peripheral blood, BM blasts <=5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement, at least 1 of the following: (i) 20,000/mm^3<=platelets<100,000/mm^3; (ii) 500/mm^3<=ANC<1000/mm^3.

Outcome measures

Measure	Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 15 mg n=1 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.	Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 30 mg: Phase 1 AP-CML n=3 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL n=6 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
Phase 2, BP-CML and Ph+ALL: Percentage of Participants With Major Hematologic Response (MaHR)	—	—	—	—	0 percentage of participants Interval 0.0 to 97.5	—	—	—	—	33.3 percentage of participants Interval 0.8 to 90.6	83.3 percentage of participants Interval 35.9 to 99.6	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 60 months

Population: Treated population included all participants who had received at least 1 dose of study drug. This outcome measure was planned to be assessed only in CP-CML Participants of Phase 1 and 2.

Hematologic response was defined as CHR for CP-CML participants. Participants who entered the trial in CHR and continued to meet the criteria for CHR on study were analyzed as responders. Response criteria for CHR was reported as WBC <=institutional ULN, platelets <450,000 per cubic millimeter (/mm^3), no blasts or promyelocytes in peripheral blood, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement (including no hepatomegaly or splenomegaly).

Outcome measures

Measure	Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 15 mg n=1 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.	Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 30 mg: Phase 1 AP-CML n=3 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL n=2 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML n=11 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
CP-CML Participants: Percentage of Participants With CHR	—	—	—	—	100 percentage of participants Interval 2.5 to 100.0	—	—	—	—	100 percentage of participants Interval 29.2 to 100.0	100 percentage of participants Interval 15.8 to 100.0	90.9 percentage of participants Interval 58.7 to 99.8	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 60 months

Population: Treated population included all participants who had received at least 1 dose of study drug.

Confirmed MCyR was defined as 2 assessments of CCyR or PCyR at least 28 days apart. Participants entering the trial in PCyR must achieve two consecutive assessments of CCyR no fewer than 28 days apart in order to be considered as meeting the criteria for confirmed MCyR. Participants entering the trial in less than PCyR must achieve two consecutive assessments of PCyR or CCyR no fewer than 28 days apart in order to be considered as meeting the criteria for confirmed MCyR. CCyR: no Ph+ cells. PCyR: 1% to 35% Ph+ cells.

Outcome measures

Measure	Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 15 mg n=1 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.	Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations n=1 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations n=11 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations n=3 Participants Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations n=6 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 30 mg: Phase 1 AP-CML n=1 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL n=4 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML n=3 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP CML n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML n=2 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Percentage of Participants With Confirmed MCyR	—	—	—	—	100 percentage of participants Interval 2.5 to 100.0	0 percentage of participants Interval 0.0 to 97.5	63.6 percentage of participants Interval 30.8 to 89.1	33.3 percentage of participants Interval 0.8 to 90.6	16.7 percentage of participants Interval 0.4 to 64.1	0 percentage of participants Interval 0.0 to 97.5	0 percentage of participants Interval 0.0 to 60.2	100 percentage of participants Interval 29.2 to 100.0	100 percentage of participants Interval 2.5 to 100.0	100 percentage of participants Interval 2.5 to 100.0	100 percentage of participants Interval 2.5 to 100.0	0 percentage of participants Interval 0.0 to 84.2

SECONDARY outcome

Timeframe: Baseline up to 60 months

Population: Treated population included all participants who had received at least 1 dose of study drug.

MMR was defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL <=0.1% on the International scale (equivalent to a 3-log reduction in transcript). Participants were non-responders in any of the following situations: BCR-ABL or ABL levels not detectable at baseline, no valid baseline or post-baseline assessment, and baseline assessment for e1a2 variant only.

Outcome measures

Measure	Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 15 mg n=1 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.	Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations n=1 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations n=11 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations n=3 Participants Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations n=6 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 30 mg: Phase 1 AP-CML n=1 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL n=4 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML n=3 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP CML n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML n=2 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Percentage of Participants With Major Molecular Response (MMR)	—	—	—	—	0 percentage of participants Interval 0.0 to 97.5	9 percentage of participants Interval 0.0 to 97.5	27.3 percentage of participants Interval 6.0 to 61.0	33.3 percentage of participants Interval 0.8 to 90.6	0 percentage of participants Interval 0.0 to 45.9	0 percentage of participants Interval 0.0 to 97.5	0 percentage of participants Interval 0.0 to 60.2	100 percentage of participants Interval 29.2 to 100.0	0 percentage of participants Interval 0.0 to 97.5	0 percentage of participants Interval 0.0 to 97.5	0 percentage of participants Interval 0.0 to 97.5	50.0 percentage of participants Interval 1.3 to 98.7

SECONDARY outcome

Timeframe: From the first dose of study treatment until the criteria for response were first met (up to 60 months)

Population: Treated population included all participants who had received at least 1 dose of study drug.

Time to response was defined as the interval from the first dose of study treatment until the criteria for response were first met, censored at the last assessment of response. Median time to response was estimated by Kaplan-Meier method.

Outcome measures

Measure	Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 15 mg n=1 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.	Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations n=2 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations n=11 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations n=3 Participants Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations n=6 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 30 mg: Phase 1 AP-CML n=1 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL n=4 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML n=3 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP CML n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML n=2 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Median Time to Response (TTR) Cytogenic response	—	—	—	—	85.0 days Interval 85.0 to 85.0	NA days Median and 95% CI were not estimable as excessive participants were censored.	167 days Interval 84.0 to 755.0	31 days Interval 31.0 to 31.0	29 days Interval 24.0 to 58.0	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	85 days Interval 85.0 to 169.0	113 days Interval 113.0 to 113.0	29 days Interval 29.0 to 29.0	28 days Interval 28.0 to 28.0	84 days Interval 84.0 to 84.0
CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Median Time to Response (TTR) Hematologic response	—	—	—	—	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	17 days Interval 17.0 to 17.0	15 days Interval 10.0 to 44.0	22 days Interval 22.0 to 22.0	14.5 days Interval 14.0 to 15.0	NA days Median and 95% CI were not estimable as excessive participants were censored.	56 days Interval 56.0 to 56.0	15 days Interval 15.0 to 15.0	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.
CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Median Time to Response (TTR) Molecular response	—	—	—	—	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	253.0 days Interval 84.0 to 842.0	58 days Interval 58.0 to 58.0	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	85 days Interval 85.0 to 421.0	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	84 days Interval 84.0 to 84.0

SECONDARY outcome

Timeframe: From the first assessment at which criteria for response was met until the criteria for progression was first met (up to 60 months)

Population: Treated population by entry mutation. Here number analyzed "n" are the participants who were evaluable for this outcome measure for given categories.

DOR: interval between first assessment at which criteria for response was met, until criteria for progression was met, censored at last date at which criteria for response was met. DOR was estimated using the Kaplan-Meier method. Progression criteria for CP was: death, development of AP/BP, or loss of CHR (in absence of cytogenic response), or loss of MCyR, or increasing WBC in participant without CHR (doubling of WBCs to >20,000 on 2 occasions at least 4 weeks apart, after first week of therapy), as confirmed by development in complete blood cells (CBCs) at least 4 weeks apart; AP was: death, development of confirmed BP, loss of previous major/minor hematologic response over-2 week period, or no decrease from baseline levels in percentage blasts in peripheral blood/BM on all assessments over a 4-week period; and BP/Ph+ALL was: death/increasing blasts in peripheral blood or BM over a 4-week period. As planned, DOR is reported for all participants by entry mutation (T315I and Other).

Outcome measures

Measure	Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations n=1 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations n=2 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 15 mg n=1 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.	Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations n=2 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations n=2 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations n=4 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 30 mg: Phase 1 AP-CML Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML n=3 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL n=2 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML n=9 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
CP-CML and Advanced Phase Participants: Median Duration of Response (DOR) Cytogenic response	—	169.0 days 95% CI were not estimable as excessive participants were censored.	—	205.0 days 95% CI were not estimable as excessive participants were censored.	1513.0 days 95% CI were not estimable as excessive participants were censored.	—	NA days Median and 95% CI were not estimable as excessive participants were censored.	—	31.0 days Interval 20.0 to 95% CI (upper limit) were not estimable as excessive participants were censored.	—	—	NA days Median and 95% CI were not estimable as excessive participants were censored.	—	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.
CP-CML and Advanced Phase Participants: Median Duration of Response (DOR) Hematologic response	NA days Median and 95% CI were not estimable as excessive participants were censored.	226.0 days 95% CI were not estimable as excessive participants were censored.	—	113.5 days Interval 110.0 to 95% CI (upper limit) were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	56.5 days Interval 38.0 to 95% CI (upper limit) were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	—	50.5 days Interval 33.0 to 95% CI (upper limit) were not estimable as excessive participants were censored.	—	—	NA days Median and 95% CI were not estimable as excessive participants were censored.	—	NA days Interval 1226.0 to Median and 95% CI (upper limit) were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Interval 85.0 to Median and 95% CI (upper limit) were not estimable as excessive participants were censored.
CP-CML and Advanced Phase Participants: Median Duration of Response (DOR) Molecular response	—	—	—	—	—	—	—	—	168.0 days 95% CI were not estimable as excessive participants were censored.	—	—	NA days Median and 95% CI were not estimable as excessive participants were censored.	—	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.

SECONDARY outcome

Timeframe: From the first assessment at which criteria for response was met until the criteria for progression or death was met (up to 60 months)

Population: Treated population by entry mutation. Here overall number analyzed "N" are the participants who were evaluable for this outcome measure.

PFS: interval from the first dose of study treatment until the criteria for progression or death were met, censored at the last response assessment. PFS was estimated using the Kaplan-Meier method. Progression criteria for CP was: death, development of AP/BP, or loss of CHR (in absence of cytogenic response), or loss of MCyR, or increasing WBC in participant without CHR (doubling of WBCs to >20,000 on 2 occasions at least 4 weeks apart, after first week of therapy), as confirmed by development in CBCs at least 4 weeks apart; AP was: death, development of confirmed BP, loss of previous major/minor hematologic response over-2 week period, or no decrease from baseline levels in percentage blasts in peripheral blood/BM on all assessments over a 4-week period; BP/Ph+ALL was: death or increasing blasts in peripheral blood or BM over a 4-week period. As planned, PFS is reported for all participants by entry mutation (T315I and Other).

Outcome measures

Measure	Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations n=2 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations n=4 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 15 mg n=1 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.	Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations n=3 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations n=2 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations n=1 Participants Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations n=5 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 30 mg: Phase 1 AP-CML Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML n=2 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML n=3 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL n=2 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML n=9 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
CP-CML and Advanced Phase Participants: Median Progression-free Survival (PFS)	56.5 days Interval 10.0 to 95% CI (upper limit) were not estimable as excessive participants were censored.	281.0 days 95% CI were not estimable as excessive participants were censored.	—	127.5 days Interval 85.0 to 95% CI (upper limit) were not estimable as excessive participants were censored.	1597.0 days 95% CI were not estimable as excessive participants were censored.	51.0 days Interval 29.0 to 95% CI (upper limit) were not estimable as excessive participants were censored.	320.0 days Interval 113.0 to 95% CI (upper limit) were not estimable as excessive participants were censored.	33.0 days 95% CI were not estimable as excessive participants were censored.	100.0 days Interval 10.0 to 95% CI (upper limit) were not estimable as excessive participants were censored.	—	—	NA days Interval 85.0 to Median and 95% CI (upper limit) were not estimable as excessive participants were censored.	—	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Interval 113.0 to Median and 95% CI (upper limit) were not estimable as excessive participants were censored.

SECONDARY outcome

Timeframe: From the first dose of study treatment until death (up to 60 months)

Population: Treated population by entry mutation. Here overall number analyzed "N" are the participants who were evaluable for this outcome measure.

OS was defined as the interval from the first dose of study treatment until death, censored at the last date at which participant was known to be alive. Overall survival was estimated using the Kaplan-Meier method. As planned, OS is reported for all participants by entry mutation (T315I and Other).

Outcome measures

Measure	Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations n=2 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations n=1 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations n=4 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 15 mg n=1 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.	Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations n=3 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations n=2 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations n=1 Participants Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations n=5 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 30 mg: Phase 1 AP-CML Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML n=2 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML n=3 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL n=2 Participants Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML n=9 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
CP-CML and Advanced Phase Participants: Overall Survival (OS)	131.0 days Interval 10.0 to 95% CI (upper limit) were not estimable as excessive participants were censored.	382.0 days 95% CI were not estimable as excessive participants were censored.	—	550.5 days Interval 281.0 to 95% CI (upper limit) were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	201.0 days Interval 194.0 to 95% CI (upper limit) were not estimable as excessive participants were censored.	NA days Interval 527.0 to Median and 95% CI (upper limit) were not estimable as excessive participants were censored.	109.0 days 95% CI were not estimable as excessive participants were censored.	264.0 days Interval 169.0 to 95% CI (upper limit) were not estimable as excessive participants were censored.	—	—	NA days Median and 95% CI were not estimable as excessive participants were censored.	—	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Median and 95% CI were not estimable as excessive participants were censored.	NA days Interval 1305.0 to Median and 95% CI (upper limit) were not estimable as excessive participants were censored.

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)

Population: Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.

Outcome measures

Measure	Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 15 mg n=3 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.	Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 30 mg: Phase 1 AP-CML n=6 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL n=6 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
Cmax: Maximum Observed Plasma Concentration for Ponatinib	—	—	—	—	23.67 nanogram per milliliter (ng/mL) Standard Deviation 7.136	—	—	—	—	31.55 nanogram per milliliter (ng/mL) Standard Deviation 9.072	89.13 nanogram per milliliter (ng/mL) Standard Deviation 24.63	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)

Population: Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.

Outcome measures

Measure	Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 15 mg n=3 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.	Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 30 mg: Phase 1 AP-CML n=6 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL n=6 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
Tmax: Time to Reach the Cmax for Ponatinib	—	—	—	—	4.00 hour Interval 4.0 to 6.2	—	—	—	—	6.75 hour Interval 3.9 to 8.1	5.00 hour Interval 4.0 to 6.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)

Population: Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.

Outcome measures

Measure	Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 15 mg n=3 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.	Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 30 mg: Phase 1 AP-CML n=6 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL n=6 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Ponatinib	—	—	—	—	336.00 hour*nanogram per milliliter (h*ng/mL) Standard Deviation 129.55	—	—	—	—	495.98 hour*nanogram per milliliter (h*ng/mL) Standard Deviation 154.09	1385.5 hour*nanogram per milliliter (h*ng/mL) Standard Deviation 456.20	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)

Population: Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.

Outcome measures

Measure	Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.	Ponatinib 15 mg n=3 Participants Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.	Ponatinib 30 mg: Phase 1 Ponatinib 30 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 Advanced Phase Participants With T315I Mutations Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.	Ponatinib 30 mg: Phase 1 AP-CML n=6 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL n=6 Participants Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
T1/2: Terminal Phase Elimination Half-life for Ponatinib	—	—	—	—	NA hours Data could not be calculated for t1/2 due to lack of PK time points beyond 24 hours post-dose.	—	—	—	—	NA hours Data could not be calculated for t1/2 due to lack of PK time points beyond 24 hours post-dose.	NA hours Data could not be calculated for t1/2 due to lack of PK time points beyond 24 hours post-dose.	—	—	—	—	—

Adverse Events

Ponatinib 30 mg: Phase 1 CP-CML

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Ponatinib 30 mg: Phase 1 AP-CML

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ponatinib 30 mg: Phase 1 Ph+ ALL

Serious events: 2 serious events

Other events: 3 other events

Deaths: 4 deaths

Ponatinib 45 mg: Phase 1 CP-CML

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Ponatinib 45 mg: Phase 1 AP-CML

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Ponatinib 45 mg: Phase 1 BP-CML

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ponatinib 45 mg: Phase 1 Ph+ ALL

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Ponatinib 15 mg: Phase 2 CP-CML

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Ponatinib 15 mg: Phase 2 Ph+ ALL

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Ponatinib 45 mg: Phase 2 CP-CML

Serious events: 6 serious events

Other events: 11 other events

Deaths: 1 deaths

Ponatinib 45 mg: Phase 2 BP-CML

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Ponatinib 45 mg: Phase 2 PH+ ALL

Serious events: 1 serious events

Other events: 6 other events

Deaths: 6 deaths

Serious adverse events

Measure	Ponatinib 30 mg: Phase 1 CP-CML n=1 participants at risk Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 AP-CML n=1 participants at risk Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL n=4 participants at risk Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML n=3 participants at risk Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP-CML n=1 participants at risk Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML n=1 participants at risk Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL n=1 participants at risk Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML n=2 participants at risk Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).	Ponatinib 15 mg: Phase 2 Ph+ ALL n=1 participants at risk Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).	Ponatinib 45 mg: Phase 2 CP-CML n=11 participants at risk Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 BP-CML n=3 participants at risk Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 PH+ ALL n=6 participants at risk Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
Cardiac disorders Myocardial Infarction	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Angina unstable	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Atrioventricular block complete	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Enteritis infectious	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Infection	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pneumonia legionella	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Sepsis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pyrexia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Cholecystitis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Hepatic failure	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Gamma-glutamyltransferase increased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Hepatic enzyme increased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diverticulum intestinal	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Ileus	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Fluid retention	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Brain stem infarction	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Reproductive system and breast disorders Genital haemorrhage	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pneumonia	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Cardiac failure acute	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Coronary artery occlusion	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Coronary artery stenosis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Cholelithiasis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Cataract	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Retinal vein occlusion	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Carotid artery stenosis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Cerebral infarction	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Mechanical ileus	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Measure	Ponatinib 30 mg: Phase 1 CP-CML n=1 participants at risk Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 AP-CML n=1 participants at risk Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 30 mg: Phase 1 Ph+ ALL n=4 participants at risk Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 CP-CML n=3 participants at risk Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 AP-CML n=1 participants at risk Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 BP-CML n=1 participants at risk Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.	Ponatinib 45 mg: Phase 1 Ph+ ALL n=1 participants at risk Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.	Ponatinib 15 mg: Phase 2 CP-CML n=2 participants at risk Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).	Ponatinib 15 mg: Phase 2 Ph+ ALL n=1 participants at risk Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).	Ponatinib 45 mg: Phase 2 CP-CML n=11 participants at risk Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 BP-CML n=3 participants at risk Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.	Ponatinib 45 mg: Phase 2 PH+ ALL n=6 participants at risk Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
Investigations Platelet count decreased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	63.6% 7/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Lipase increased	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	27.3% 3/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Gamma-glutamyltransferase increased	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 2/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Alanine aminotransferase increased	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 2/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 2/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Aspartate aminotransferase increased	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 2/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 2/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood alkaline phosphatase increased	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Neutrophil count decreased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	36.4% 4/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Weight decreased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Amylase increased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Weight increased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations White blood cell count decreased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood creatinine increased	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations C-reactive protein increased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Lymphocyte count decreased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood uric acid increased	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Anal incontinence	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood cholesterol increased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood creatine phosphokinase decreased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood phosphorus increased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood urea increased	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Brain natriuretic peptide increased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Ejection fraction decreased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Electrocardiogram t wave inversion	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Hyperkalaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Hypertension	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Hypotension	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Protein C decreased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Urine output decreased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 4/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 2/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Drug eruption	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	36.4% 4/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Erythema	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Asteatosis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Papule	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pyrexia	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 2/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 2/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	54.5% 6/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Oedema peripheral	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	27.3% 3/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Malaise	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Fatigue	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Face oedema	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Hyperthermia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Chest pain	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Peripheral swelling	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 2/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Constipation	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	27.3% 3/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Haemorrhoids	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal distension	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Proctalgia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Angular cheilitis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Ascites	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Chronic gastritis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Dental caries	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Food poisoning	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Gastritis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Gingival pain	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Hiatus hernia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Odynophagia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Proctitis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Tooth loss	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Periarthritis	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Platelet count decreased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 2/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	27.3% 3/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Neutrophil count decreased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders White blood cell count decreased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Nephrogenic anaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Nasopharyngitis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Conjunctivitis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Gastroenteritis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Bronchitis	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Gingivitis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pharyngitis	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Skin infection	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Bacterial infection	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Conjunctivitis bacterial	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Gastroenteritis norovirus	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Gastrointestinal infection	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Hordeolum	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Impetigo	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Oral candidiasis	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Paronychia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Perirectal abscess	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pneumonia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pyoderma	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Sinusitis	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Tinea infection	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Tinea pedis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Fluid retention	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Blood cholesterol increased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypouricaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Steroid diabetes	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hypertension	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	54.5% 6/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hypotension	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Peripheral coldness	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	27.3% 3/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Neuralgia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	27.3% 3/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Carotid artery stenosis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Cerebral artery occlusion	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dementia alzheimers type	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dizziness	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Hemiplegia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Hypoaesthesia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Parkinsons disease	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Ocular hyperaemia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Post herpetic neuralgia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Presyncope	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Seizure	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Trigeminal neuralgia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Renal impairment	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Dysuria	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Tubulointerstitial nephritis	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Calculus urinary	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Hypertensive nephropathy	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Proteinuria	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Urethral pain	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Allergic transfusion reaction	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Cystitis radiation	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Post procedural inflammation	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Radiation skin injury	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 1/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Tooth avulsion	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Cataract	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.2% 2/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Conjunctival haemorrhage	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders CONJUNCTIVITIS allergic	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Corneal disorder	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Dry eye	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Eye pain	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Glaucoma	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Macular degeneration	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Uveitis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Insomnia	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	36.4% 4/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Anxiety disorder	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Delirium	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Bradycardia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Angina pectoris	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Atrioventricular block complete	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Cardiac aneurysm	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Cardiac discomfort	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Cardiac failure	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Palpitations	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Pericardial effusion	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 2/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Blood bilirubin increased	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 1/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Cholelithiasis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Endocrine disorders Hypothyroidism	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Endocrine disorders Hyperthyroidism	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Reproductive system and breast disorders Gynaecomastia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Reproductive system and breast disorders Menstrual disorder	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.1% 1/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Ear and labyrinth disorders Ear congestion	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pain	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/2 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/1 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
• Publication restrictions are in place

Restriction type: OTHER