Trial Outcomes & Findings for A Safety and Pharmacokinetic Study of TAK-228 in Combination With TAK-117 in Adult Participants With Advanced Nonhematologic Malignancies (NCT NCT01899053)

NCT ID: NCT01899053

Last Updated: 2019-10-30

Results Overview

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above-mentioned criteria.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 101 participants
• Primary outcome timeframe: From Baseline to 30 days after the last dose of study drug (Up to approximately 68 weeks)
• Results posted on: 2019-10-30

Participant Flow

Participants took part in the study at 5 investigative sites in Spain, United Kingdom and United States from 28 June 2013 to 30 April 2018.

Participants with a diagnosis of advanced nonhematologic malignancies were enrolled. A total of 101 participants were enrolled, out of which 81 entered the escalation phase, and 20 entered the expansion phase.

Participant milestones

Measure	Dose Escalation Treatment Arm A: Cohort 1A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Overall Study STARTED	7	3	7	3	6	3	3	3	6	3	16	7	14	20
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	7	3	7	3	6	3	3	3	6	3	16	7	14	20

Reasons for withdrawal

Measure	Dose Escalation Treatment Arm A: Cohort 1A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Overall Study Progressive Disease	4	0	3	0	3	1	1	1	4	3	12	5	8	17
Overall Study Adverse Event	1	1	1	3	1	1	1	0	2	0	3	1	2	2
Overall Study Reason Not Specified	0	0	0	0	0	0	1	0	0	0	0	0	1	0
Overall Study Withdrawal by Subject	1	1	2	0	2	0	0	1	0	0	0	0	1	1
Overall Study Protocol Violation	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Overall Study Unsatisfactory Therapeutic Response	1	1	0	0	0	0	0	0	0	0	1	0	0	0
Overall Study Symptomatic Deterioration	0	0	0	0	0	1	0	1	0	0	0	1	2	0

Baseline Characteristics

A Safety and Pharmacokinetic Study of TAK-228 in Combination With TAK-117 in Adult Participants With Advanced Nonhematologic Malignancies

Baseline characteristics by cohort

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 Participants TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) n=20 Participants TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.	Total n=101 Participants Total of all reporting groups
Age, Continuous	59.9 years STANDARD_DEVIATION 6.31 • n=5 Participants	69.3 years STANDARD_DEVIATION 5.13 • n=7 Participants	50.6 years STANDARD_DEVIATION 14.05 • n=5 Participants	66.7 years STANDARD_DEVIATION 5.86 • n=4 Participants	48.7 years STANDARD_DEVIATION 11.66 • n=21 Participants	74.3 years STANDARD_DEVIATION 5.13 • n=10 Participants	69.3 years STANDARD_DEVIATION 14.15 • n=115 Participants	68.3 years STANDARD_DEVIATION 9.24 • n=6 Participants	58.0 years STANDARD_DEVIATION 7.72 • n=6 Participants	68.3 years STANDARD_DEVIATION 4.16 • n=64 Participants	56.6 years STANDARD_DEVIATION 9.69 • n=17 Participants	53.3 years STANDARD_DEVIATION 14.36 • n=21 Participants	56.5 years STANDARD_DEVIATION 6.97 • n=22 Participants	63.4 years STANDARD_DEVIATION 9.10 • n=8 Participants	59.4 years STANDARD_DEVIATION 10.96 • n=16 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=6 Participants	4 Participants n=6 Participants	2 Participants n=64 Participants	11 Participants n=17 Participants	2 Participants n=21 Participants	7 Participants n=22 Participants	13 Participants n=8 Participants	64 Participants n=16 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=6 Participants	2 Participants n=6 Participants	1 Participants n=64 Participants	5 Participants n=17 Participants	5 Participants n=21 Participants	7 Participants n=22 Participants	7 Participants n=8 Participants	37 Participants n=16 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=64 Participants	1 Participants n=17 Participants	0 Participants n=21 Participants	1 Participants n=22 Participants	4 Participants n=8 Participants	8 Participants n=16 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=10 Participants	3 Participants n=115 Participants	2 Participants n=6 Participants	5 Participants n=6 Participants	2 Participants n=64 Participants	13 Participants n=17 Participants	7 Participants n=21 Participants	13 Participants n=22 Participants	9 Participants n=8 Participants	81 Participants n=16 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants	2 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	7 Participants n=8 Participants	12 Participants n=16 Participants
Race/Ethnicity, Customized White	7 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=10 Participants	3 Participants n=115 Participants	3 Participants n=6 Participants	4 Participants n=6 Participants	3 Participants n=64 Participants	13 Participants n=17 Participants	4 Participants n=21 Participants	14 Participants n=22 Participants	19 Participants n=8 Participants	90 Participants n=16 Participants
Race/Ethnicity, Customized Black Or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	1 Participants n=17 Participants	3 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	5 Participants n=16 Participants
Race/Ethnicity, Customized Asian	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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	2 Participants n=16 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=64 Participants	1 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	1 Participants n=8 Participants	3 Participants n=16 Participants
Race/Ethnicity, Customized Other	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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	1 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	1 Participants n=16 Participants
Region of Enrollment United Kingdom	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=10 Participants	0 Participants n=115 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=64 Participants	3 Participants n=17 Participants	1 Participants n=21 Participants	2 Participants n=22 Participants	1 Participants n=8 Participants	11 Participants n=16 Participants
Region of Enrollment Spain	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	3 Participants n=6 Participants	1 Participants n=64 Participants	5 Participants n=17 Participants	1 Participants n=21 Participants	4 Participants n=22 Participants	12 Participants n=8 Participants	31 Participants n=16 Participants
Region of Enrollment United States	7 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants	1 Participants n=64 Participants	8 Participants n=17 Participants	5 Participants n=21 Participants	8 Participants n=22 Participants	7 Participants n=8 Participants	59 Participants n=16 Participants
Height	164.0 cm STANDARD_DEVIATION 3.84 • n=5 Participants	165.1 cm STANDARD_DEVIATION 5.08 • n=7 Participants	161.6 cm STANDARD_DEVIATION 3.26 • n=5 Participants	159.4 cm STANDARD_DEVIATION 7.73 • n=4 Participants	169.8 cm STANDARD_DEVIATION 8.73 • n=21 Participants	169.0 cm STANDARD_DEVIATION 12.86 • n=10 Participants	157.3 cm STANDARD_DEVIATION 4.25 • n=115 Participants	168.5 cm STANDARD_DEVIATION 15.02 • n=6 Participants	168.3 cm STANDARD_DEVIATION 12.41 • n=6 Participants	168.5 cm STANDARD_DEVIATION 8.30 • n=64 Participants	168.7 cm STANDARD_DEVIATION 11.24 • n=17 Participants	180.7 cm STANDARD_DEVIATION 9.35 • n=21 Participants	170.7 cm STANDARD_DEVIATION 7.86 • n=22 Participants	163.7 cm STANDARD_DEVIATION 7.64 • n=8 Participants	167.3 cm STANDARD_DEVIATION 9.67 • n=16 Participants
Weight	63.8 kg STANDARD_DEVIATION 9.11 • n=5 Participants	78.4 kg STANDARD_DEVIATION 1.34 • n=7 Participants	69.7 kg STANDARD_DEVIATION 14.20 • n=5 Participants	49.8 kg STANDARD_DEVIATION 8.06 • n=4 Participants	79.5 kg STANDARD_DEVIATION 19.91 • n=21 Participants	67.6 kg STANDARD_DEVIATION 20.33 • n=10 Participants	62.5 kg STANDARD_DEVIATION 15.32 • n=115 Participants	73.7 kg STANDARD_DEVIATION 17.32 • n=6 Participants	78.2 kg STANDARD_DEVIATION 22.65 • n=6 Participants	79.3 kg STANDARD_DEVIATION 9.11 • n=64 Participants	71.4 kg STANDARD_DEVIATION 13.00 • n=17 Participants	79.9 kg STANDARD_DEVIATION 15.19 • n=21 Participants	78.6 kg STANDARD_DEVIATION 17.55 • n=22 Participants	64.6 kg STANDARD_DEVIATION 12.08 • n=8 Participants	71.4 kg STANDARD_DEVIATION 15.63 • n=16 Participants
Body Mass Index (BMI)	23.7 kg/m^2 STANDARD_DEVIATION 2.80 • n=5 Participants	28.8 kg/m^2 STANDARD_DEVIATION 2.09 • n=7 Participants	26.7 kg/m^2 STANDARD_DEVIATION 5.65 • n=5 Participants	19.9 kg/m^2 STANDARD_DEVIATION 5.06 • n=4 Participants	27.3 kg/m^2 STANDARD_DEVIATION 5.09 • n=21 Participants	23.2 kg/m^2 STANDARD_DEVIATION 3.36 • n=10 Participants	25.4 kg/m^2 STANDARD_DEVIATION 7.18 • n=115 Participants	26.2 kg/m^2 STANDARD_DEVIATION 6.76 • n=6 Participants	27.2 kg/m^2 STANDARD_DEVIATION 4.60 • n=6 Participants	27.9 kg/m^2 STANDARD_DEVIATION 3.11 • n=64 Participants	25.2 kg/m^2 STANDARD_DEVIATION 4.30 • n=17 Participants	24.3 kg/m^2 STANDARD_DEVIATION 3.27 • n=21 Participants	27.0 kg/m^2 STANDARD_DEVIATION 5.74 • n=22 Participants	24.1 kg/m^2 STANDARD_DEVIATION 4.06 • n=8 Participants	25.4 kg/m^2 STANDARD_DEVIATION 4.66 • n=16 Participants

PRIMARY outcome

Timeframe: From Baseline to 30 days after the last dose of study drug (Up to approximately 68 weeks)

Population: Safety population consisted of all enrolled participants who received at least 1 dose of any study drug.

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above-mentioned criteria.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 Participants TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) n=20 Participants TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Event (TEAEs) and Serious Adverse Events (SAEs) AEs	7 Participants	3 Participants	7 Participants	3 Participants	5 Participants	3 Participants	3 Participants	3 Participants	6 Participants	3 Participants	16 Participants	7 Participants	14 Participants	19 Participants
Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Event (TEAEs) and Serious Adverse Events (SAEs) SAEs	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	4 Participants	4 Participants	6 Participants	9 Participants

PRIMARY outcome

Timeframe: Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose

Population: Pharmacokinetic (PK) population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 Participants TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Tmax: Time to Reach the Maximum Observed Plasma Concentration After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort Cycle 1, Day 1	1.000 hour Interval 0.5 to 4.0	1.000 hour Interval 0.97 to 1.03	1.000 hour Interval 0.5 to 4.07	2.050 hour Interval 0.53 to 2.07	1.033 hour Interval 1.0 to 2.08	2.083 hour Interval 1.97 to 4.02	1.000 hour Interval 0.48 to 1.07	1.067 hour Interval 1.03 to 8.12	1.358 hour Interval 0.5 to 4.0	1.067 hour Interval 0.98 to 3.83	1.000 hour Interval 0.5 to 2.15	0.725 hour Interval 0.43 to 2.08	0.983 hour Interval 0.47 to 4.17	—
Tmax: Time to Reach the Maximum Observed Plasma Concentration After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort Cycle 1, Day 24	1.000 hour Interval 0.5 to 2.0	0.758 hour Interval 0.48 to 1.03	1.400 hour Interval 0.45 to 4.08	—	2.000 hour Interval 0.92 to 2.25	4.000 hour Interval 1.0 to 4.12	1.408 hour Interval 1.0 to 1.82	0.617 hour Interval 0.48 to 2.0	0.925 hour Interval 0.5 to 2.15	4.000 hour Interval 4.0 to 4.0	1.033 hour Interval 0.47 to 2.3	2.083 hour Interval 1.95 to 4.87	1.017 hour Interval 0.5 to 7.03	—

PRIMARY outcome

Timeframe: Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 Participants TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Cmax: Maximum Observed Plasma Concentration After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort Cycle 1, Day 1	24.63 ng/mL Standard Deviation 7.355	39.73 ng/mL Standard Deviation 7.853	25.80 ng/mL Standard Deviation 8.188	28.67 ng/mL Standard Deviation 3.702	18.26 ng/mL Standard Deviation 8.610	21.69 ng/mL Standard Deviation 29.273	48.90 ng/mL Standard Deviation 28.157	33.30 ng/mL Standard Deviation 16.301	53.10 ng/mL Standard Deviation 7.257	53.53 ng/mL Standard Deviation 29.788	42.17 ng/mL Standard Deviation 11.495	27.53 ng/mL Standard Deviation 11.665	26.51 ng/mL Standard Deviation 12.788	—
Cmax: Maximum Observed Plasma Concentration After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort Cycle 1, Day 24	27.78 ng/mL Standard Deviation 6.632	53.55 ng/mL Standard Deviation 2.192	29.45 ng/mL Standard Deviation 9.746	—	13.75 ng/mL Standard Deviation 6.938	37.36 ng/mL Standard Deviation 49.078	46.10 ng/mL Standard Deviation 17.253	72.43 ng/mL Standard Deviation 13.094	61.58 ng/mL Standard Deviation 14.894	17.1 ng/mL Standard Deviation 0	50.68 ng/mL Standard Deviation 12.055	17.75 ng/mL Standard Deviation 4.865	35.59 ng/mL Standard Deviation 18.415	—

PRIMARY outcome

Timeframe: Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 Participants TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Observed Quantifiable Concentration After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort Cycle 1, Day 1	120.888 ng*hr/mL Standard Deviation 36.1184	247.361 ng*hr/mL Standard Deviation 156.0211	138.929 ng*hr/mL Standard Deviation 37.3727	230.983 ng*hr/mL Standard Deviation 14.6292	109.622 ng*hr/mL Standard Deviation 45.6613	126.062 ng*hr/mL Standard Deviation 120.8204	303.897 ng*hr/mL Standard Deviation 152.5659	287.283 ng*hr/mL Standard Deviation 268.7088	351.602 ng*hr/mL Standard Deviation 122.6407	382.588 ng*hr/mL Standard Deviation 250.2623	249.341 ng*hr/mL Standard Deviation 128.4868	168.408 ng*hr/mL Standard Deviation 103.9245	160.670 ng*hr/mL Standard Deviation 90.6815	—
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Observed Quantifiable Concentration After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort Cycle 1, Day 24	206.418 ng*hr/mL Standard Deviation 169.5373	208.389 ng*hr/mL Standard Deviation 78.6461	200.762 ng*hr/mL Standard Deviation 56.1368	—	115.884 ng*hr/mL Standard Deviation 50.7913	203.836 ng*hr/mL Standard Deviation 120.1336	410.604 ng*hr/mL Standard Deviation 265.8768	535.365 ng*hr/mL Standard Deviation 256.8762	331.286 ng*hr/mL Standard Deviation 133.7879	305.97 ng*hr/mL Standard Deviation 0	317.111 ng*hr/mL Standard Deviation 151.6045	132.058 ng*hr/mL Standard Deviation 71.7154	211.792 ng*hr/mL Standard Deviation 100.9091	—

PRIMARY outcome

Timeframe: Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 Participants TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Terminal Phase Elimination Half-life (T1/2) After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort Cycle 1, Day 24	5.489 hour Standard Deviation 2.4782	4.686 hour Standard Deviation 2.1265	5.521 hour Standard Deviation 1.6417	—	7.635 hour Standard Deviation 1.1253	5.43 hour Standard Deviation 0	8.5 hour Standard Deviation 0	6.808 hour Standard Deviation 1.7326	6.221 hour Standard Deviation 1.0591	—	5.940 hour Standard Deviation 1.6737	6.42 hour Standard Deviation 0	6.354 hour Standard Deviation 1.9320	—
Terminal Phase Elimination Half-life (T1/2) After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort Cycle 1, Day 1	5.090 hour Standard Deviation 2.1653	5.783 hour Standard Deviation 3.3941	6.214 hour Standard Deviation 2.6649	7.450 hour Standard Deviation 0.7368	6.975 hour Standard Deviation 1.0108	4.65 hour Standard Deviation 0	8.412 hour Standard Deviation 1.3996	4.96 hour Standard Deviation 0	5.792 hour Standard Deviation 3.4405	6.799 hour Standard Deviation 5.5740	6.320 hour Standard Deviation 1.7839	5.512 hour Standard Deviation 2.1598	7.593 hour Standard Deviation 1.1365	—

PRIMARY outcome

Timeframe: Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled during the dose escalation and expansion stage of the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants who were evaluable at each category.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 Participants TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Concentration After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort Cycle 1, Day 1	16.534 L/hour Standard Deviation 5.4762	19.049 L/hour Standard Deviation 11.8558	14.419 L/hour Standard Deviation 7.5636	7.694 L/hour Standard Deviation 0.5750	15.311 L/hour Standard Deviation 3.6762	11.38 L/hour Standard Deviation 0	10.728 L/hour Standard Deviation 6.9669	28.54 L/hour Standard Deviation 0	19.999 L/hour Standard Deviation 10.0509	16.259 L/hour Standard Deviation 9.3725	17.924 L/hour Standard Deviation 9.5261	22.715 L/hour Standard Deviation 14.7252	13.933 L/hour Standard Deviation 5.4880	—
CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Concentration After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort Cycle 1, Day 24	14.720 L/hour Standard Deviation 4.5824	18.207 L/hour Standard Deviation 4.1819	10.597 L/hour Standard Deviation 3.9917	—	15.683 L/hour Standard Deviation 2.9149	9.23 L/hour Standard Deviation 0	13.58 L/hour Standard Deviation 0	12.817 L/hour Standard Deviation 4.7929	19.060 L/hour Standard Deviation 7.1913	—	14.196 L/hour Standard Deviation 5.3137	15.53 L/hour Standard Deviation 0	16.133 L/hour Standard Deviation 8.6701	—

PRIMARY outcome

Timeframe: Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Overall number of participants analyzed is the number of participants with evaluable data at both Days 1 and 24.

Accumulation ratio was based on AUC(0-24) between Cycle 1 Day 24 and Cycle 1 Day 1 (e.g. AUC(0-24) [Cycle 1 Day 24]/ AUC(0-24) [Cycle1 Day 1].

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=3 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=1 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=4 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=3 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=2 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=2 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=2 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=2 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=1 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=8 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=2 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=6 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
RAC: Accumulation Ratio for TAK-228 in the Dose Escalation Cohort	2.225 ratio Standard Deviation 1.4576	1.25 ratio Standard Deviation 0	1.495 ratio Standard Deviation 0.1884	—	1.219 ratio Standard Deviation 0.3497	1.569 ratio Standard Deviation 0.4099	1.712 ratio Standard Deviation 0.2650	1.718 ratio Standard Deviation 0.4329	1.015 ratio Standard Deviation 0.1453	1.58 ratio Standard Deviation 0	1.172 ratio Standard Deviation 0.3363	1.213 ratio Standard Deviation 0.1306	1.461 ratio Standard Deviation 0.2246	—

PRIMARY outcome

Timeframe: Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 Participants TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Peak to Trough Ratio for TAK-228 After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort Cycle 1, Day 1	16.546 ratio Standard Deviation 6.5659	13.588 ratio Standard Deviation 8.3649	14.553 ratio Standard Deviation 6.8807	10.420 ratio Standard Deviation 1.5662	13.983 ratio Standard Deviation 6.6782	23.757 ratio Standard Deviation 31.1525	14.336 ratio Standard Deviation 7.0986	20.212 ratio Standard Deviation 22.0357	13.227 ratio Standard Deviation 8.3834	5.761 ratio Standard Deviation 1.5250	22.676 ratio Standard Deviation 14.2142	15.012 ratio Standard Deviation 6.5253	10.725 ratio Standard Deviation 2.7876	—
Peak to Trough Ratio for TAK-228 After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort Cycle 1, Day 24	12.145 ratio Standard Deviation 6.0465	27.66 ratio Standard Deviation 0	14.691 ratio Standard Deviation 8.1076	—	9.363 ratio Standard Deviation 6.6336	21.864 ratio Standard Deviation 33.1541	9.305 ratio Standard Deviation 4.7969	21.979 ratio Standard Deviation 13.7911	31.971 ratio Standard Deviation 19.6410	1.8 ratio Standard Deviation 0	22.555 ratio Standard Deviation 10.4006	8.805 ratio Standard Deviation 7.3805	21.157 ratio Standard Deviation 14.9668	—

PRIMARY outcome

Timeframe: Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 Participants TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) After Single-dose and Multiple-dose of TAK-117 in the Dose Escalation Cohort Cycle 1, Day 24	1.000 hour Interval 0.55 to 4.0	1.025 hour Interval 1.02 to 1.03	4.108 hour Interval 0.93 to 8.02	—	2.417 hour Interval 1.97 to 4.0	2.000 hour Interval 1.92 to 4.0	1.408 hour Interval 1.0 to 1.82	0.883 hour Interval 0.62 to 4.05	3.150 hour Interval 2.0 to 7.02	7.33 hour Interval 7.33 to 7.33	2.000 hour Interval 1.0 to 8.02	2.050 hour Interval 1.4 to 4.27	1.117 hour Interval 0.95 to 8.07	—
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) After Single-dose and Multiple-dose of TAK-117 in the Dose Escalation Cohort Cycle 1, Day 1	0.800 hour Interval 0.5 to 2.03	2.000 hour Interval 1.03 to 2.0	2.050 hour Interval 0.52 to 4.08	2.050 hour Interval 1.03 to 2.07	3.017 hour Interval 1.85 to 7.5	1.97 hour Interval 1.97 to 1.97	2.000 hour Interval 1.07 to 4.18	1.033 hour Interval 0.5 to 8.12	4.008 hour Interval 0.5 to 7.25	3.883 hour Interval 2.42 to 7.33	1.925 hour Interval 1.0 to 4.15	2.083 hour Interval 0.95 to 6.03	3.125 hour Interval 0.5 to 22.58	—

PRIMARY outcome

Timeframe: Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 Participants TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Cmax: Maximum Observed Plasma Concentration After Single-dose and Multiple-dose of TAK-117 in the Dose Escalation Cohort Cycle 1, Day 1	1800.0 ng/mL Standard Deviation 1049.25	988.7 ng/mL Standard Deviation 858.57	3067.1 ng/mL Standard Deviation 1243.50	4950.0 ng/mL Standard Deviation 3381.06	4136.7 ng/mL Standard Deviation 1487.68	2420 ng/mL Standard Deviation 0	3836.7 ng/mL Standard Deviation 656.07	1631.3 ng/mL Standard Deviation 1305.25	2711.7 ng/mL Standard Deviation 1172.97	2568.7 ng/mL Standard Deviation 2107.04	3369.4 ng/mL Standard Deviation 1417.31	3077.7 ng/mL Standard Deviation 1629.05	3353.0 ng/mL Standard Deviation 1955.02	—
Cmax: Maximum Observed Plasma Concentration After Single-dose and Multiple-dose of TAK-117 in the Dose Escalation Cohort Cycle 1, Day 24	2514.0 ng/mL Standard Deviation 1597.13	2720.0 ng/mL Standard Deviation 1286.93	3438.3 ng/mL Standard Deviation 1687.00	—	3624.0 ng/mL Standard Deviation 2925.79	1054.8 ng/mL Standard Deviation 1454.94	6180.0 ng/mL Standard Deviation 127.28	4876.7 ng/mL Standard Deviation 848.84	4477.5 ng/mL Standard Deviation 953.88	100 ng/mL Standard Deviation 0	4863.3 ng/mL Standard Deviation 1142.54	3755.0 ng/mL Standard Deviation 2831.78	4805.3 ng/mL Standard Deviation 2893.99	—

PRIMARY outcome

Timeframe: Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 Participants TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Observed Quantifiable Concentration After Single-dose and Multiple-dose of TAK-117 in Dose Escalation Cohort Cycle 1, Day 1	14586.139 ng*hr/mL Standard Deviation 10434.5445	11550.908 ng*hr/mL Standard Deviation 11672.0852	43948.190 ng*hr/mL Standard Deviation 25421.3428	69617.994 ng*hr/mL Standard Deviation 46233.0898	54993.211 ng*hr/mL Standard Deviation 27446.4517	26746.78 ng*hr/mL Standard Deviation 0	47803.262 ng*hr/mL Standard Deviation 4758.7418	23148.610 ng*hr/mL Standard Deviation 27836.8878	38563.109 ng*hr/mL Standard Deviation 23484.8077	39903.517 ng*hr/mL Standard Deviation 33243.1212	38224.835 ng*hr/mL Standard Deviation 22368.0163	30925.255 ng*hr/mL Standard Deviation 15126.4913	46451.606 ng*hr/mL Standard Deviation 33137.8861	—
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Observed Quantifiable Concentration After Single-dose and Multiple-dose of TAK-117 in Dose Escalation Cohort Cycle 1, Day 24	31723.844 ng*hr/mL Standard Deviation 38363.4872	22566.251 ng*hr/mL Standard Deviation 13562.8900	50960.181 ng*hr/mL Standard Deviation 32295.5320	—	46278.615 ng*hr/mL Standard Deviation 48171.7982	12428.783 ng*hr/mL Standard Deviation 16745.7861	90462.795 ng*hr/mL Standard Deviation 14090.4676	67186.097 ng*hr/mL Standard Deviation 49493.0584	55908.919 ng*hr/mL Standard Deviation 39888.9699	1674.23 ng*hr/mL Standard Deviation 0	72432.560 ng*hr/mL Standard Deviation 27615.6802	46164.679 ng*hr/mL Standard Deviation 37938.0208	70490.572 ng*hr/mL Standard Deviation 58515.7794	—

PRIMARY outcome

Timeframe: Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 Participants TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Terminal Phase Elimination Half-life (T1/2) After Single-dose and Multiple-dose of TAK-117 in Dose Escalation Cohort Cycle 1, Day 24	5.722 hour Standard Deviation 3.1259	6.53 hour Standard Deviation 0	2.98 hour Standard Deviation 0	—	3.2 hour Standard Deviation 0	8.37 hour Standard Deviation 0	—	6.233 hour Standard Deviation 4.4813	4.61 hour Standard Deviation 0	—	7.717 hour Standard Deviation 2.6428	5.853 hour Standard Deviation 2.1534	5.984 hour Standard Deviation 3.6558	—
Terminal Phase Elimination Half-life (T1/2) After Single-dose and Multiple-dose of TAK-117 in Dose Escalation Cohort Cycle 1, Day 1	6.590 hour Standard Deviation 3.4673	4.92 hour Standard Deviation 0	—	—	—	—	—	3.839 hour Standard Deviation 3.5498	7.465 hour Standard Deviation 2.2023	—	4.858 hour Standard Deviation 2.7928	6.379 hour Standard Deviation 1.5369	7.368 hour Standard Deviation 0.3774	—

PRIMARY outcome

Timeframe: Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 Participants TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Concentration After Single-dose and Multiple-dose of TAK-117 in Dose Escalation Cohort Cycle 1, Day 1	16.993 L/hr Standard Deviation 23.6496	9.79 L/hr Standard Deviation 0	—	—	—	—	—	194.998 L/hr Standard Deviation 258.2751	20.944 L/hr Standard Deviation 16.6625	—	17.879 L/hr Standard Deviation 17.8072	21.075 L/hr Standard Deviation 16.4116	32.455 L/hr Standard Deviation 35.8687	—
CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Concentration After Single-dose and Multiple-dose of TAK-117 in Dose Escalation Cohort Cycle 1, Day 24	13.821 L/hr Standard Deviation 16.5047	7.18 L/hr Standard Deviation 0	17.95 L/hr Standard Deviation 0	—	9.25 L/hr Standard Deviation 0	19.7 L/hr Standard Deviation 0	—	5.328 L/hr Standard Deviation 1.2794	5.45 L/hr Standard Deviation 0	—	4.803 L/hr Standard Deviation 2.7599	11.199 L/hr Standard Deviation 8.4334	67.750 L/hr Standard Deviation 110.0873	—

PRIMARY outcome

Timeframe: Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Overall number of participants analyzed is the number of participants with evaluable data at both Days 1 and 24.

Accumulation ratio was based on AUC(0-24) between Cycle 1 Day 24 and Cycle 1 Day 1 (e.g. AUC(0-24) [Cycle 1 Day 24]/ AUC(0-24) [Cycle1 Day 1].

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=4 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=1 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=5 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=5 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=1 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=2 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=2 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=3 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=1 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=9 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=9 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
RAC: Accumulation Ratio for TAK-117 in the Dose Escalation Cohort	0.965 ratio Standard Deviation 0.1423	1.33 ratio Standard Deviation 0	1.161 ratio Standard Deviation 0.2506	—	1.049 ratio Standard Deviation 0.9033	1.18 ratio Standard Deviation 0	2.007 ratio Standard Deviation 0.4766	2.687 ratio Standard Deviation 0.5700	1.748 ratio Standard Deviation 1.1575	0.91 ratio Standard Deviation 0	1.879 ratio Standard Deviation 1.5772	0.925 ratio Standard Deviation 0.6281	4.183 ratio Standard Deviation 5.8060	—

PRIMARY outcome

Timeframe: Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 Participants TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Peak to Trough Ratio After Single-dose and Multiple-dose of TAK-117 in Dose Escalation Cohort Cycle 1, Day 1	20.138 ratio Standard Deviation 21.6013	8.845 ratio Standard Deviation 7.8516	2.551 ratio Standard Deviation 0.9673	2.676 ratio Standard Deviation 0.1635	4.373 ratio Standard Deviation 3.3285	3.93 ratio Standard Deviation 0	3.602 ratio Standard Deviation 0.8361	6.640 ratio Standard Deviation 7.3746	6.877 ratio Standard Deviation 8.8600	2.631 ratio Standard Deviation 0.5993	6.872 ratio Standard Deviation 8.3680	11.494 ratio Standard Deviation 10.9430	3.426 ratio Standard Deviation 2.3804	—
Peak to Trough Ratio After Single-dose and Multiple-dose of TAK-117 in Dose Escalation Cohort Cycle 1, Day 24	10.023 ratio Standard Deviation 9.0435	11.256 ratio Standard Deviation 7.1426	2.294 ratio Standard Deviation 0.5975	—	20.124 ratio Standard Deviation 33.8991	3.931 ratio Standard Deviation 2.4369	3.464 ratio Standard Deviation 0.1399	54.242 ratio Standard Deviation 87.1445	11.832 ratio Standard Deviation 15.4766	1.96 ratio Standard Deviation 0	5.482 ratio Standard Deviation 6.7075	11.184 ratio Standard Deviation 8.0869	4.664 ratio Standard Deviation 3.9973	—

PRIMARY outcome

Timeframe: Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 10 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=20 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Tmax: Time to Reach the Maximum Observed Plasma Concentration for TAK-228 in DDI Expansion Cohort Cycle 1, Day 3, TAK-228 administered alone	1.000 hour Interval 0.38 to 4.08	—	—	—	—	—	—	—	—	—	—	—	—	—
Tmax: Time to Reach the Maximum Observed Plasma Concentration for TAK-228 in DDI Expansion Cohort Cycle 1, Day 10, TAK-228 administered with TAK-117	0.983 hour Interval 0.42 to 2.02	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 10 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=20 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Cmax: Maximum Observed Plasma Concentration for TAK-228 in DDI Expansion Cohort Cycle 1, Day 10, TAK-228 administered with TAK-117	71.99 ng/mL Standard Deviation 22.546	—	—	—	—	—	—	—	—	—	—	—	—	—
Cmax: Maximum Observed Plasma Concentration for TAK-228 in DDI Expansion Cohort Cycle 1, Day 3, TAK-228 administered alone	60.02 ng/mL Standard Deviation 21.808	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 10 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=20 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Observed Quantifiable Concentration for TAK-228 in DDI Expansion Cohort Cycle 1, Day 3, TAK-228 administered alone	301.613 ng*hr/mL Standard Deviation 123.9584	—	—	—	—	—	—	—	—	—	—	—	—	—
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Observed Quantifiable Concentration for TAK-228 in DDI Expansion Cohort Cycle 1, Day 10, TAK-228 administered with TAK-117	390.307 ng*hr/mL Standard Deviation 155.3378	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 10 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=20 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Terminal Phase Elimination Half-life (T1/2) for TAK-228 in DDI Expansion Cohort Cycle 1, Day 3, TAK-228 administered alone	6.823 hour Standard Deviation 2.1608	—	—	—	—	—	—	—	—	—	—	—	—	—
Terminal Phase Elimination Half-life (T1/2) for TAK-228 in DDI Expansion Cohort Cycle 1, Day 10, TAK-228 administered with TAK-117	6.546 hour Standard Deviation 1.8351	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 10 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=20 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-228 in DDI Expansion Cohort Cycle 1, Day 3, TAK-228 administered alone	15.368 L/hour Standard Deviation 10.9714	—	—	—	—	—	—	—	—	—	—	—	—	—
CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-228 in DDI Expansion Cohort Cycle 1, Day 10, TAK-228 administered with TAK-117	13.359 L/hour Standard Deviation 11.3718	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 10 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=20 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Peak to Trough Ratio for TAK-228 in DDI Expansion Cohort Cycle 1, Day 3, TAK-228 administered alone	22.982 ratio Standard Deviation 11.6286	—	—	—	—	—	—	—	—	—	—	—	—	—
Peak to Trough Ratio for TAK-228 in DDI Expansion Cohort Cycle 1, Day 10, TAK-228 administered with TAK-117	23.931 ratio Standard Deviation 15.6395	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 17 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=20 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Tmax: Time to Reach the Maximum Observed Plasma Concentration for TAK-117 in DDI Expansion Cohort Cycle 1, Day 10, TAK-117 administered with TAK-228	1.033 hour Interval 0.5 to 4.12	—	—	—	—	—	—	—	—	—	—	—	—	—
Tmax: Time to Reach the Maximum Observed Plasma Concentration for TAK-117 in DDI Expansion Cohort Cycle 1, Day 17, TAK-117 administered alone	1.983 hour Interval 0.5 to 7.25	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 17 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=20 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Cmax: Maximum Observed Plasma Concentration for TAK-117 in DDI Expansion Cohort Cycle 1, Day 10, TAK-117 administered with TAK-228	5357.3 ng/mL Standard Deviation 2842.40	—	—	—	—	—	—	—	—	—	—	—	—	—
Cmax: Maximum Observed Plasma Concentration for TAK-117 in DDI Expansion Cohort Cycle 1, Day 17, TAK-117 administered alone	5332.6 ng/mL Standard Deviation 2955.51	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 17 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=20 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Observed Quantifiable Concentration for TAK-117 in DDI Expansion Cohort Cycle 1, Day 10, TAK-117 administered with TAK-228	61148.949 ng*hr/mL Standard Deviation 42799.7918	—	—	—	—	—	—	—	—	—	—	—	—	—
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Observed Quantifiable Concentration for TAK-117 in DDI Expansion Cohort Cycle 1, Day 17, TAK-117 administered alone	63975.156 ng*hr/mL Standard Deviation 53764.5716	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 17 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=20 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Terminal Phase Elimination Half-life (T1/2) for TAK-117 in DDI Expansion Cohort Cycle 1, Day 10, TAK-117 administered with TAK-228	6.420 hour Standard Deviation 2.3635	—	—	—	—	—	—	—	—	—	—	—	—	—
Terminal Phase Elimination Half-life (T1/2) for TAK-117 in DDI Expansion Cohort Cycle 1, Day 17, TAK-117 administered alone	5.717 hour Standard Deviation 2.3715	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 17 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=20 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-117 in DDI Expansion Cohort Cycle 1, Day 10, TAK-117 administered with TAK-228	11.797 L/hour Standard Deviation 18.0040	—	—	—	—	—	—	—	—	—	—	—	—	—
CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-117 in DDI Expansion Cohort Cycle 1, Day 17, TAK-117 administered alone	9.134 L/hour Standard Deviation 8.7741	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 17 predose and at multiple timepoints (up to 24 hours) postdose

Population: PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=20 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Peak to Trough Ratio for TAK-117 in DDI Expansion Cohort Cycle 1, Day 10, TAK-117 administered with TAK-228	7.423 ratio Standard Deviation 7.423	—	—	—	—	—	—	—	—	—	—	—	—	—
Peak to Trough Ratio for TAK-117 in DDI Expansion Cohort Cycle 1, Day 17, TAK-117 administered alone	21.357 ratio Standard Deviation 44.3461	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Days 22 up to Day 28 of Cycle and every even-numbered cycle until disease progression or EOS (Up to approximately 68 weeks)

Population: Safety population consisted of all enrolled participants who received at least 1 dose of any study drug.

ORR defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 for target lesions and assessed by CT or MRI. CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter (LD) of target lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 Participants TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 Participants TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 Participants TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 Participants TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 Participants TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 Participants TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 Participants TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 Participants TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 Participants TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 Participants TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) n=20 Participants TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Objective Response Rate (ORR) Based on Investigator's Assessment According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	20.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Days 22 up to Day 28 of Cycle and every even-numbered cycle until disease progression or EOS (Up to approximately 68 weeks)

Population: Safety population consisted of all enrolled participants who received at least 1 dose of any study drug. Data for this outcome measure is reported for the participants with objective response available.

The DOR is defined as the time from the date of first documented response of CR/PR to the first documented progressive disease (PD), or censored at the last response assessment date that is SD or better for a participant that has not progressed. CR was defined as the disappearance of all target lesions and for non-target lesions, the disappearance of all non-target lesions and normalization of tumor marker level. PR was defined of at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD and for non-target lesions.

Outcome measures

Measure	Dose Escalation Treatment Arm A: Cohort 1A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) n=4 Participants TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Duration of Response (DOR)	—	—	—	—	—	—	—	—	—	—	—	—	—	92 days Interval 1.0 to 288.0

Adverse Events

Dose Escalation Treatment Arm A: Cohort 1A

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Dose Escalation Treatment Arm A: Cohort 2A

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Escalation Treatment Arm A: Cohort 3A

Serious events: 1 serious events

Other events: 7 other events

Deaths: 1 deaths

Dose Escalation Treatment Arm A: Cohort 3A (Milled)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Escalation Treatment Arm A: Cohort 4A

Serious events: 1 serious events

Other events: 5 other events

Deaths: 1 deaths

Dose Escalation Treatment Arm B: Cohort 1B

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Escalation Treatment Arm B: Cohort 2B

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Escalation Treatment Arm B: Cohort 3B

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Escalation Treatment Arm B: Cohort 3B (Milled)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Dose Escalation Treatment Arm B: Cohort 4B

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Escalation Treatment Arm B: Cohort 5B (Milled)

Serious events: 4 serious events

Other events: 16 other events

Deaths: 2 deaths

Dose Escalation Treatment Arm C: Cohort 1C

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

Dose Escalation Treatment Arm C: Cohort 2C (Milled)

Serious events: 6 serious events

Other events: 13 other events

Deaths: 0 deaths

Drug-Drug Interaction (DDI) Expansion Cohort (Milled)

Serious events: 9 serious events

Other events: 19 other events

Deaths: 2 deaths

Serious adverse events

Measure	Dose Escalation Treatment Arm A: Cohort 1A n=7 participants at risk TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 participants at risk TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 participants at risk TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 participants at risk TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 participants at risk TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 participants at risk TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 participants at risk TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 participants at risk TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 participants at risk TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 participants at risk TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 participants at risk TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 participants at risk TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 participants at risk TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) n=20 participants at risk TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
Hepatobiliary disorders Cholecystitis	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Dysphagia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Enterocolitis	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Intestinal obstruction	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Intestinal perforation	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Upper gastrointestinal haemorrhage	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 General physical health deterioration	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Asthenia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Gait disturbance	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Bile duct obstruction	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Clostridium difficile colitis	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Peritonitis	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Urinary tract infection	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Urosepsis	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Humerus fracture	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Transaminases increased	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hypercalcaemia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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) Endometrial cancer	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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) Malignant neoplasm progression	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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) Salivary gland cancer	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 fistulisation	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Ischaemic stroke	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Nerve compression	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Confusional state	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Pneumothorax	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 embolism	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Embolism	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	Dose Escalation Treatment Arm A: Cohort 1A n=7 participants at risk TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 4 cycles (each cycle was 28 days), up to 16 weeks.	Dose Escalation Treatment Arm A: Cohort 2A n=3 participants at risk TAK-228 4 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 100 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 3 cycles (each cycle was 28 days), up to 10.4 weeks.	Dose Escalation Treatment Arm A: Cohort 3A n=7 participants at risk TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 5 cycles (each cycle was 28 days), up to 21.0 weeks.	Dose Escalation Treatment Arm A: Cohort 3A (Milled) n=3 participants at risk TAK-228 2 mg, capsule (milled), orally, once daily every day (QD), and TAK-117 200 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 2 cycles (each cycle was 28 days), up to 6.1 weeks.	Dose Escalation Treatment Arm A: Cohort 4A n=6 participants at risk TAK-228 2 mg, capsule (unmilled), orally, once daily every day (QD), and TAK-117 300 mg, capsule, orally, once on Monday, Wednesday and Friday each week (MWF QW) for up to 13 cycles (each cycle was 28 days), up to approximately 52 weeks.	Dose Escalation Treatment Arm B: Cohort 1B n=3 participants at risk TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 100 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 23.4 weeks.	Dose Escalation Treatment Arm B: Cohort 2B n=3 participants at risk TAK-228 3 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 6 cycles (each cycle was 28 days), up to 21.3 weeks.	Dose Escalation Treatment Arm B: Cohort 3B n=3 participants at risk TAK-228 6 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 5 cycles (each cycle was 28 days), up to 19.4 weeks.	Dose Escalation Treatment Arm B: Cohort 3B (Milled) n=6 participants at risk TAK-228 6 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 4 cycles (each cycle was 28 days), up to 15.4 weeks.	Dose Escalation Treatment Arm B: Cohort 4B n=3 participants at risk TAK-228 8 mg, capsule (unmilled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 2 cycles (each cycle was 28 days), up to 7.4 weeks.	Dose Escalation Treatment Arm B: Cohort 5B (Milled) n=16 participants at risk TAK-228 4 mg, capsule (milled), orally, once on Monday, Tuesday and Wednesday each week (MTuW QW), and TAK-117 200 mg, capsule, orally, once on MTuW QW for up to 9 cycles (each cycle was 28 days), up to 38.7 weeks.	Dose Escalation Treatment Arm C: Cohort 1C n=7 participants at risk TAK-228 3 mg, capsule (unmilled), orally, once on MTuW QW, and TAK-117 400 mg, capsule, orally, once on MTuW QW for up to 17 cycles (each cycle was 28 days), up to 64.3 weeks.	Dose Escalation Treatment Arm C: Cohort 2C (Milled) n=14 participants at risk TAK-228 3 mg, capsule (milled), orally, once on MTuW QW, and TAK-117 300 mg, capsule, orally, once on MTuW QW for up to 11 cycles (each cycle was 28 days), up to 43.4 weeks.	Drug-Drug Interaction (DDI) Expansion Cohort (Milled) n=20 participants at risk TAK-228 4 mg, capsule (milled), orally, once on MTuW QW except on Days 15, 16 and 17 of Cycle 1, and TAK-117 200 mg, capsule, orally, once on MTuW QW except on Days 1, 2 and 3 of Cycle 1 for up to 8 cycles (each cycle was 28 days), up to approximately 31.4 weeks.
General disorders Oedema peripheral	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	21.4% 3/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Chills	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	21.4% 3/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 2/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	21.4% 3/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Thrombocytopenia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Tachycardia	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	21.4% 3/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	42.9% 3/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	85.7% 6/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	68.8% 11/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	57.1% 4/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	71.4% 10/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	55.0% 11/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	71.4% 5/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 8/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	64.3% 9/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	45.0% 9/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	42.9% 3/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	37.5% 6/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 7/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	30.0% 6/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	21.4% 3/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	35.0% 7/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	21.4% 3/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	15.0% 3/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	15.0% 3/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 upper	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	15.0% 3/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Gastrooesophageal reflux disease	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 2/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Oral pain	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	21.4% 3/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Flatulence	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Dysphagia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Oesophagitis	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Mouth ulceration	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	42.9% 3/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	37.5% 6/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 6/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.0% 4/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Asthenia	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 2/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 4/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 10/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	21.4% 3/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hyperbilirubinaemia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Urinary tract infection	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	15.0% 3/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Upper respiratory tract infection	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	15.0% 3/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Cystitis	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Laceration	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	21.4% 3/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	21.4% 3/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Transaminases increased	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 4/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 5/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 glucose increased	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	42.9% 3/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 2/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 4/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.0% 4/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 4/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 4/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 2/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 4/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	15.0% 3/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 2/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hypomagnesaemia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hyponatraemia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	21.4% 3/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 2/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hypercholesterolaemia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	15.0% 3/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	21.4% 3/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.0% 4/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	15.0% 3/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 chest pain	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 pain	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Muscular weakness	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	15.0% 3/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Dysgeusia	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.0% 4/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Tremor	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Confusional state	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	15.0% 3/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 4/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 2/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	15.0% 3/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Depression	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Urinary incontinence	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	42.9% 3/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.8% 3/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Epistaxis	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Paranasal sinus hypersecretion	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Pneumonitis	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 maculo-papular	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 macular	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 generalised	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 2/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 2/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Deep vein thrombosis	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Arteriosclerosis	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Lymphopenia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Neutropenia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Sinus Tachycardia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Congenital, familial and genetic disorders Atrial Septal Defect	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Deafness Transitory	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Discomfort	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Tinnitus	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Vision Blurred	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Visual Impairment	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Diplopia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Oedema	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Haematochezia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Lower	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Tenderness	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Anorectal Discomfort	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Cheilitis	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Eructation	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Gastrointestinal Disorder	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Gastrointestinal Inflammation	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Tongue Oedema	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Toothache	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Gait Disturbance	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Non-Cardiac Chest Pain	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Discomfort	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Early Satiety	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hernia Pain	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Infusion Site Extravasation	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Medical Device Site Pain	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Puncture Site Pain	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Temperature Intolerance	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Unevaluable Event	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Herpes	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Cellulitis	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Ear Infection	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Fungal Infection	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Puncture Site Infection	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Tooth Infection	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Urinary Tract Infection Bacterial	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Vulvovaginal Candidiasis	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Wound Infection	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Gastrointestinal Disorder Postoperative	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Stoma Site Pain	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Abrasion	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Complication	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Bilirubin Increased	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Qt Prolonged	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Platelet Count Decreased	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Albumin Decreased	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Sodium Decreased	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Haemoglobin Decreased	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Laryngeal Oedema	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hypercalcaemia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Malnutrition	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Fistula	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Twitching	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Diplegia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Dysarthria	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Restless Legs Syndrome	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Speech Disorder	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Syncope	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Vocal Cord Paralysis	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Depressed Mood	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Libido Decreased	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Haematuria	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Bladder Spasm	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hydronephrosis	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Urinary Hesitation	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Urinary Retention	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Pelvic Pain	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Breast Oedema	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Breast Tenderness	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Vulvovaginal Burning Sensation	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Vulvovaginal Discomfort	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Vulvovaginal Pruritus	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Dysphonia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Exertional	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Haemoptysis	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Paranasal Sinus Discomfort	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Wheezing	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Apnoea	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Aspiration	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Bronchospasm	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Nasal Congestion	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Orthopnoea	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Pneumonia Aspiration	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Rhonchi	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Palmar-Plantar Erythrodysaesthesia Syndrome	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Flushing	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Haematoma	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hot Flush	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Lymphoedema	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Orthostatic Hypotension	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Vena Cava Embolism	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Venous Thrombosis	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Swelling Face	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Acne Cystic	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 1/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Leukoplakia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 1/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Onychalgia	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Onychoclasis	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Pain Of Skin	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Pruritic	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Lesion	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Ulcer	14.3% 1/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Urticaria	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Lymphadenopathy	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/16 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 1/20 • Baseline up to 30 days after the last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
• Publication restrictions are in place

Restriction type: OTHER